U.S. patent application number 17/684811 was filed with the patent office on 2022-06-16 for compositions of herbal formulations and uses thereof.
The applicant listed for this patent is HAUS BIOCEUTICALS, INC.. Invention is credited to Philip Alex, Michael Centola, Adam Joshua Payne, Tomy Yesudas.
Application Number | 20220184169 17/684811 |
Document ID | / |
Family ID | |
Filed Date | 2022-06-16 |
United States Patent
Application |
20220184169 |
Kind Code |
A1 |
Yesudas; Tomy ; et
al. |
June 16, 2022 |
COMPOSITIONS OF HERBAL FORMULATIONS AND USES THEREOF
Abstract
Disclosed herein are herbal formulations for relief from
symptoms of skin disease. The formulations can also be combined
with an active or inactive pharmaceutical ingredient, and/or a
pharmaceutically acceptable excipient.
Inventors: |
Yesudas; Tomy; (Kollam
Kerala, IN) ; Alex; Philip; (Abingdon, MD) ;
Centola; Michael; (Oklahoma City, OK) ; Payne; Adam
Joshua; (Edmond, OK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
HAUS BIOCEUTICALS, INC. |
Oklahoma City |
OK |
US |
|
|
Appl. No.: |
17/684811 |
Filed: |
March 2, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16842528 |
Apr 7, 2020 |
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17684811 |
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15889921 |
Feb 6, 2018 |
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16842528 |
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14733771 |
Jun 8, 2015 |
9889174 |
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15889921 |
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13471913 |
May 15, 2012 |
9050359 |
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14733771 |
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61486724 |
May 16, 2011 |
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International
Class: |
A61K 36/90 20060101
A61K036/90; A61K 36/23 20060101 A61K036/23; A61K 36/185 20060101
A61K036/185; A61K 36/22 20060101 A61K036/22; A61K 36/71 20060101
A61K036/71; A61K 36/899 20060101 A61K036/899; A61K 36/31 20060101
A61K036/31; A61K 36/76 20060101 A61K036/76; A61K 36/66 20060101
A61K036/66; A61K 36/29 20060101 A61K036/29; A61K 36/48 20060101
A61K036/48; A61K 36/28 20060101 A61K036/28; A61K 36/27 20060101
A61K036/27; A61K 36/68 20060101 A61K036/68; A61K 36/77 20060101
A61K036/77; A61K 36/808 20060101 A61K036/808; A61K 36/35 20060101
A61K036/35; A61K 36/24 20060101 A61K036/24 |
Claims
1. A composition comprising: a mixture of at least four different
plant extracts, wherein each of the at least four plant extracts is
selected from the group consisting of Achillea millefolium;
Aesuculus hippocastanum; Althaea officinalis; Avena sativa;
Berberis vulgaris; Capsella bursa-pastoris; Cochlearia officinalis;
Conium maculatium; Ervum lens; Hamamelis virginiana; Hydrastis
canadensis; Malva sylvestris; Matricaria chamomilla; Nasturtium
officinale; Phytolacca decendra; Pimpinella saxifraga; Populus
alba; Populus tremuloides; Rhus toxicodendron; Sambucus nigra;
Sanguinaria canadensis; Scrophularia nodosa; Smilax medica;
Tussilago farfara; Veronica officinalis; Vincetoxicum officinale;
and combinations thereof; and at least one pharmaceutically
acceptable carrier, diluent, or excipient.
2. The composition of claim 1, wherein the mixture comprises at
least five different plant extracts.
3. The composition of claim 1, wherein the mixture comprises at
least six different plant extracts.
4. The composition of claim 1, wherein the mixture comprises at
least seven different plant extracts.
5. The composition of claim 1, wherein the mixture comprises at
least eight different plant extracts.
6. The composition of claim 1, wherein the mixture comprises at
least nine different plant extracts.
7. The composition of claim 1, wherein the mixture comprises at
least ten different plant extracts.
8. The composition of claim 1, wherein the mixture comprises at
least eleven different plant extracts.
9. The composition of claim 1, wherein the mixture comprises at
least twelve different plant extracts.
10. The composition of claim 1, wherein the mixture comprises at
least thirteen different plant extracts.
11. The composition of claim 1, wherein the mixture comprises at
least fourteen different plant extracts.
12. The composition of claim 1, wherein the mixture comprises at
least fifteen different plant extracts.
13. The composition of claim 1, wherein the mixture comprises at
least sixteen different plant extracts.
14. The composition of claim 1, wherein the mixture comprises at
least seventeen different plant extracts.
15. The composition of claim 1, wherein the mixture comprises at
least eighteen different plant extracts.
16. The composition of claim 1, wherein the mixture comprises plant
extracts obtained from Achillea millefolium; Aesuculus
hippocastanum; Althaea officinalis; Avena sativa; Berberis
vulgaris; Capsella Bursa Pastoris; Cochlearia officinalis; Ervum
lens; Hamamelis virginiana; Matricaria chamomilla; Nasturtium
officinale; Phytolacca decandra; Pimpinella saxifraga; Populas
alba; Populus tremuloides; Sambucus nigra; Sanguinaria Canadensis;
Scrophularia nodosa; Smilax medica; Tussilago farfara; Veronica
officinalis; and Vincetoxicum officinale.
17. The composition of claim 1, wherein the composition is in the
form of an oral composition.
18. The composition of claim 1, wherein the composition is in the
form of a topical composition, and wherein the topical composition
is formulated as a cream, gel, lotion, ointment, or salve.
19. A method of reducing symptoms associated with a skin condition
in a subject, wherein the skin condition is associated with acne
vulgaris, psoriasis, eczema, atopic dermatitis, pruritis, erythema,
or excoriations, the method comprising the steps of: identifying
the subject in need thereof; and administering to the subject an
effective amount of the composition of claim 1.
20. The method of claim 19, wherein the composition is topically
administered to the subject.
Description
CROSS REFERENCE TO RELATED APPLICATIONS/INCORPORATION BY
REFERENCE
[0001] This application is a continuation of U.S. patent
application Ser. No. 15/889,921, filed Feb. 6, 2018, which is a
continuation of U.S. patent application Ser. No. 14/733,771, filed
Jun. 8, 2015, now U.S. Pat. No. 9,889,174, issued Feb. 13, 2018,
which is a continuation of U.S. patent application Ser. No.
13/471,913, filed May 5, 2012, now U.S. Pat. No. 9,050,359, issued
Jun. 9, 2015, which claims priority to U.S. Provisional Application
No. 61/486,724, filed May 16, 2011, which is incorporated herein by
reference in its entirety, including the drawings.
BACKGROUND
[0002] Human bodies have evolved over millions of years in harmony
with nature. Certain natural products induce the human body to
function more efficiently at combating disease and adverse
conditions. These products help the human body heal itself. Skin
conditions, the most visible of human maladies, have historically
received the most attention when it comes to the application of
herbal remedies. Herbs have been used in the healing of adverse
skin conditions for thousands of years. Aloe vera, for example, is
an herbal extract that has been used throughout history as a skin
soothant and healant. Even today, lotions containing aloe vera are
used to help skin to heal after sunburn.
[0003] Despite advances in science, skin conditions remain
prevalent and the alleviation of symptoms remains elusive. Humans
must return to nature from whence they came to find suitable relief
for these conditions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0004] FIG. 1 is a graph showing the results of the application of
the HAT-01 formulation to psoriasis patients.
[0005] FIG. 2 is an illustration of the pilot trial study design
conducted to evaluate the safety, benefit & tolerability of
HAT-01 in patients with atopic dermatitis
[0006] FIG. 3 demonstrates the benefit of HAT-01 in a study of
patients with atopic dermatitis.
[0007] FIG. 4 illustrates the benefit of HAT-01 in a study in
patients with atopic dermatitis.
DETAILED DESCRIPTION
[0008] Disclosed herein are herbal compositions, based on a
proprietary preparation of traditional commonly used herbs. Our
studies have demonstrated that these formulations are potent and
safe agents with benefit in aiding the body to alleviate the
symptoms of chronic skin conditions as described herein.
[0009] Disclosed herein are compositions comprising a mixture of
plant extracts obtained from at least two plants selected from the
group consisting of: Achillea millefolium; Aesuculus hippocastanum;
Althaea officinalis; Avena sativa; Berberis vulgaris; Capsella
Bursa Pastoris; Cochlearia officinalis; Conium maculatium; Ervum
lens; Hamamelis virginiana; Hydrastis canadensis; Matricaria
chamomilla; Nasturtium officinale; Phytolacca decendra; Pimpinella
saxifraga; Populas alba; Populus tremuloides; Rhus toxicodendron;
Sambucus nigra; Sanguinaria Canadensis; Scrophularia nodosa; Smilax
medica; Tussilago farfara; Veronica officinalis; and Vincetoxicum
officinale. Also disclosed are compositions comprising the above
compositions and a pharmaceutically acceptable carrier, diluents,
or excipient. In addition, disclosed herein are methods of treating
skin conditions by using the above compositions.
[0010] Thus, in a first non-limiting aspect, disclosed herein are
complex herbal preparations containing a unique mixture of
traditional commonly used multiple herbs. In some embodiments, the
mixture comprises four herbal extract components. In certain
embodiments, the disclosed preparations comprise plant
extracts.
[0011] The term "plant extract" or "plant extracts" as used herein
refers to a composition of extracted plant substances, including
but not limited to: juices; macerations; concentrates; syrups;
cold, heated, fluid and/or fermented extracts; powders; tablets;
tinctures; herbal teas in the form of infusions or decoctions;
poultices; lotions; creams; gels; ointments; salves; liniments;
balms; oils; essential oils; suspensions; emulsions; compresses;
dressings; fomentations; eyebaths; gargles; enemas; boluses; and
other forms of extracted plant substances such as are known to
those of ordinary skill in the arts of pharmacognosy, herbalism,
and medicinal formulation. As used herein the term "plant extract"
or "plant extracts" further contemplates the use of a solvent known
to practitioners in this art for the purpose of extraction and or
formulation, including but not limited to the use of one or more
solvents such as water, an alcohol, a polyhydric alcohol, an ether,
an ester, a carboxylic acid, an amide, a carbonate, supercritical
fluid carbon dioxide, an ionic liquid, an alkane, a
petroleum-derived oil, a plant oil, or another solvent, wherein the
solvent employed is optionally part of a pH-adjusted medium. The
term "plant extract" or "plant extracts" as used herein further
contemplates that the extract may have been obtained by the use of
one or more methods such as expression, absorption by steeping or
otherwise, maceration, distillation, evaporation optionally with
vacuum enhancement, freeze drying, and other methods known in the
arts of substance isolation from natural sources.
[0012] In some embodiments, the disclosed preparations comprise a
mixture of plant extracts from at least two plants selected from
the group consisting of: Achillea millefolium (Yarrow); Aesuculus
hippocastanum (Horsechestnut); Althaea officinalis (Althea mallow,
or Marsh Mallow); Avena sativa (Oat); Berberis vulgaris (Barberry
shrub); Capsella Bursa Pastoris (Shepherd's Purse); Cochlearia
officinalis (Spoon Wort); Conium maculatium (Hemlock); Ervum lens
(Lentil); Hamamelis virginiana (Virginium Hamamelis); Hydrastis
canadensis (Orange Root); Matricaria chamomilla (Chamomil);
Nasturtium officinale (Watercress); Phytolacca decendra (Poke
Root); Pimpinella saxifraga (Pimpernal); Populas alba (White
poplar); Populus tremuloides (Trembling poplar; Quaking Aspen,
Trembling Aspen, Quakies); Rhus toxicodendron (Ivy); Sambucus nigra
(Elderberry); Sanguinaria Canadensis (Canadian Blood root);
Scrophularia nodosa (Figwort); Smilax medica (Sarasaparrilla);
Tussilago farfara (Coltsfoot); Veronica officinalis (Speedwell);
and Vincetoxicum officinale (Swallow Wort).
[0013] In some embodiments the herbal preparations disclosed herein
comprise at least one herbal extract in the following amount (w/w):
[0014] Achillea millefolium from about 0.01% to about 20%; [0015]
Aesuculus hippocastanum from about 0.01% to about 20%; [0016]
Althaea officinalis from about 0.01% to about 20%; [0017] Avena
sativa from about 0.01% to about 25%; [0018] Berberis vulgaris from
about 0.01% to about 20%; [0019] Capsella Bursa Pastoris from about
0.01% to about 20%; [0020] Cochlearia officinalis from about 0.01%
to about 20%; [0021] Conium maculatium from about 0.01% to about
35%; [0022] Ervum lens from about 0.01% to about 20%; [0023]
Hamamelis virginiana from about 0.01% to about 25%; [0024]
Hydrastis canadensis from about 0.01% to about 20%; [0025]
Matricaria chamomilla from about 0.01% to about 20%; [0026]
Nasturtium officinale from about 0.01% to about 15%; [0027]
Phytolacca decendra from about 0.01% to about 20%; [0028]
Pimpinella saxifraga from about 0.01% to about 20%; [0029] Populas
alba from about 0.01% to about 20%; [0030] Populus tremuloides from
about 0.01% to about 20%; [0031] Rhus toxicodendron from about
0.01% to about 25%; [0032] Sambucus nigra from about 0.01% to about
20; [0033] Sanguinaria Canadensis from about 0.01% to about 20%;
[0034] Scrophularia nodosa from about 0.01% to about 20%; [0035]
Smilax medica from about 0.01% to about 20%; [0036] Tussilago
farfara from about 0.01% to about 15%; [0037] Veronica officinalis
from about 0.010% to about 15%; and [0038] Vincetoxicum officinale
from about 0.01% to about 15%.
[0039] Throughout the present disclosure the term "about" a certain
value means that a range of value.+-.20%, such as (but not limited
to) a range of value.+-.10%, is contemplated. Thus, for example,
having about 20% w/w of an ingredient includes the ingredient being
present between 16% and 24%, such as (but not limited to) between
18% and 22%.
[0040] In some embodiments the herbal preparations disclosed herein
comprise Achillea millefolium from about 1% to about 15%; or from
about 1% to about 10%; or from about 1% to about 8%; or from about
1.5% to about 7%; or from about 2% to about 6%. In some embodiments
the herbal preparations disclosed herein comprise Achillea
millefolium in about 2.5%, while in other embodiments comprise
about 5%.
[0041] In some embodiments the herbal preparations disclosed herein
comprise Aesuculus hippocastanum from about 1% to about 15%; or
from about 1% to about 10%; or from about 1% to about 8%; or from
about 1.5% to about 7%; or from about 2% to about 6%. In some
embodiments the herbal preparations disclosed herein comprise
Aesuculus hippocastanum in about 2.4%, while in other embodiments
comprise about 5%.
[0042] In some embodiments the herbal preparations disclosed herein
comprise Althaea officinalis from about 1% to about 15%; or from
about 1% to about 10%; or from about 1% to about 8%; or from about
1.5% to about 7%; or from about 1.5% to about 5%. In some
embodiments the herbal preparations disclosed herein comprise
Althaea officinalis in about 2.0%, while in other embodiments
comprise about 4%.
[0043] In some embodiments the herbal preparations disclosed herein
comprise Avena sativa from about 1% to about 25%; or from about 3%
to about 20%; or from about 5% to about 17%; or from about 5% to
about 15%. In some embodiments the herbal preparations disclosed
herein comprise Avena sativa in about 6.8%, while in other
embodiments comprise about 14%.
[0044] In some embodiments the herbal preparations disclosed herein
comprise Berberis vulgaris from about 1% to about 17%; or from
about 1% to about 15%; or from about 3% to about 12%; or from about
3% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Berberis vulgaris in about 4.1%, while in
other embodiments comprise about 8%.
[0045] In some embodiments the herbal preparations disclosed herein
comprise Capsella Bursa Pastoris from about 1% to about 17%; or
from about 1% to about 15%; or from about 1.5% to about 12%; or
from about 1.5% to about 10%. In some embodiments the herbal
preparations disclosed herein comprise Capsella Bursa Pastoris in
about 2.2%, while in other embodiments comprise about 8%.
[0046] In some embodiments the herbal preparations disclosed herein
comprise Cochlearia officinalis from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
4% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Cochlearia officinalis in about 5.1%,
while in other embodiments comprise about 10%.
[0047] In some embodiments the herbal preparations disclosed herein
comprise Conium maculatium from about 1% to about 30%; or from
about 1% to about 25%; or or from about 3.5% to about 23%. In some
embodiments the herbal preparations disclosed herein comprise
Conium maculatium in about 4%, in other embodiments comprise about
12.1%, while in yet other embodiments comprise about 21%.
[0048] In some embodiments the herbal preparations disclosed herein
comprise Ervum lens from about 1% to about 17%; or from about 1% to
about 15%; or from about 3% to about 12%; or from about 3% to about
10%. In some embodiments the herbal preparations disclosed herein
comprise Ervum lens in about 3.7%, while in other embodiments
comprise about 8%.
[0049] In some embodiments the herbal preparations disclosed herein
comprise Hamamelis virginiana from about 1% to about 25%; or from
about 3% to about 20%; or from about 5% to about 17%; or from about
5% to about 15%. In some embodiments the herbal preparations
disclosed herein comprise Hamamelis virginiana in about 8.9%, while
in other embodiments comprise about 13%.
[0050] In some embodiments the herbal preparations disclosed herein
comprise Hydrastis canadensis from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
3.5% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Hydrastis canadensis in about 5%, in
other embodiments comprise about 6.0%, while in yet other
embodiments comprise about 8%.
[0051] In some embodiments the herbal preparations disclosed herein
comprise Matricaria chamomilla from about 1% to about 17%; or from
about 1% to about 15%; or from about 1.5% to about 12%; or from
about 1.5% to about 10%. In some embodiments the herbal
preparations disclosed herein comprise Matricaria chamomilla in
about 2.2%, while in other embodiments comprise about 8%.
[0052] In some embodiments the herbal preparations disclosed herein
comprise Nasturtium officinale from about 0.01% to about 12%; or
from about 0.01% to about 10%; or from about 0.1% to about 8%; or
from about 0.1% to about 5%. In some embodiments the herbal
preparations disclosed herein comprise Nasturtium officinale in
about 0.9%, while in other embodiments comprise about 2%.
[0053] In some embodiments the herbal preparations disclosed herein
comprise Phytolacca decendra from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
3.5% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Phytolacca decendra in about 4%, in other
embodiments comprise about 5.8%, while in yet other embodiments
comprise about 8%.
[0054] In some embodiments the herbal preparations disclosed herein
comprise Pimpinella saxifraga from about 0.01% to about 12%; or
from about 0.01% to about 10%; or from about 0.1% to about 8%; or
from about 0.5% to about 5%. In some embodiments the herbal
preparations disclosed herein comprise Pimpinella saxifraga in
about 1.1%, while in other embodiments comprise about 2%.
[0055] In some embodiments the herbal preparations disclosed herein
comprise Populas alba from about 1% to about 17%; or from about 3%
to about 15%; or from about 3% to about 12%; or from about 4% to
about 10%. In some embodiments the herbal preparations disclosed
herein comprise Populas alba in about 4.9%, while in other
embodiments comprise about 10%.
[0056] In some embodiments the herbal preparations disclosed herein
comprise Populus tremuloides from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
4% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Populus tremuloides in about 4.8%, while
in other embodiments comprise about 10%.
[0057] In some embodiments the herbal preparations disclosed herein
comprise Rhus toxicodendron from about 1% to about 25%; or from
about 3% to about 20%; or from about 5% to about 20%; or from about
7% to about 20%. In some embodiments the herbal preparations
disclosed herein comprise Rhus toxicodendron in about 8.3%, while
in other embodiments comprise about 17%.
[0058] In some embodiments the herbal preparations disclosed herein
comprise Sambucus nigra from about 1% to about 15%; or from about
1% to about 10%; or from about 1% to about 8%; or from about 1.5%
to about 7%; or from about 1.5% to about 6%. In some embodiments
the herbal preparations disclosed herein comprise Sambucus nigra in
about 1.9%, while in other embodiments comprise about 4%.
[0059] In some embodiments the herbal preparations disclosed herein
comprise Sanguinaria Canadensis from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
4% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Sanguinaria Canadensis in about 4.5%,
while in other embodiments comprise about 9%.
[0060] In some embodiments the herbal preparations disclosed herein
comprise Scrophularia nodosa from about 1% to about 17%; or from
about 3% to about 15%; or from about 3% to about 12%; or from about
4% to about 10%. In some embodiments the herbal preparations
disclosed herein comprise Scrophularia nodosa in about 4.0%, while
in other embodiments comprise about 8%.
[0061] In some embodiments the herbal preparations disclosed herein
comprise Smilax medica from about 1% to about 15%; or from about 1%
to about 10%; or from about 1% to about 8%; or from about 1.5% to
about 7%; or from about 2% to about 6.5%. In some embodiments the
herbal preparations disclosed herein comprise Smilax medica in
about 3.1%, while in other embodiments, comprise about 6%.
[0062] In some embodiments the herbal preparations disclosed herein
comprise Tussilago farfara from about 0.01% to about 12%; or from
about 0.01% to about 10%; or from about 0.1% to about 8%; or from
about 0.1% to about 5%. In some embodiments the herbal preparations
disclosed herein comprise Tussilago farfara in about 0.9%, while in
other embodiments comprise about 2%.
[0063] In some embodiments the herbal preparations disclosed herein
comprise Veronica officinalis from about 0.01% to about 12%; or
from about 0.01% to about 10%; or from about 0.1% to about 8%; or
from about 0.1% to about 5%. In some embodiments the herbal
preparations disclosed herein comprise Veronica officinalis in
about 0.8%, while in other embodiments comprise about 2%.
[0064] In some embodiments the herbal preparations disclosed herein
comprise Vincetoxicum officinale from about 0.01% to about 12%; or
from about 0.01% to about 10%; or from about 0.1% to about 8%; or
from about 0.1% to about 5%. In some embodiments the herbal
preparations disclosed herein comprise Vincetoxicum officinale in
about 0.9%, while in other embodiments comprise about 2%.
[0065] In one embodiment, the herbal preparation disclosed herein
comprises Mixture I. Mixture I comprises plant extracts obtained
from the following plants: Althaea officinalis; Ervum lens; Populas
alba; Populus tremuloides; Conium maculatium; Sambucus nigra;
Hamamelis virginiana; and Phytolacca decendra.
[0066] In another embodiment, the herbal preparation disclosed
herein comprises Mixture II. Mixture II comprises plant extracts
obtained from the following plants: Conium maculatium; Phytolacca
decendra; Pimpinella saxifraga; Rhus toxicodendron; and
Vincetoxicum officinale.
[0067] In yet another embodiment, the herbal preparation disclosed
herein comprises Mixture III. Mixture III comprises plant extracts
obtained from the following plants: Avena sativa; Aesuculus
hippocastanum; Capsella Bursa Pastoris; Hamamelis virginiana;
Hydrastis canadensis; Achillea millefolium; and Sanguinaria
Canadensis.
[0068] In still another embodiment, the herbal preparation
disclosed herein comprises Mixture IV. Mixture IV comprises plant
extracts obtained from the following plants: Berberis vulgaris;
Matricaria chamomilla; Cochlearia officinalis; Hydrastis
canadensis; Nasturtium officinale; Scrophularia nodosa; Smilax
medica; Tussilago farfara; and Veronica officinalis.
[0069] In one embodiment, the herbal preparation disclosed herein
comprises Mixture V. Mixture V comprises plant extracts obtained
from the following plants: Berberis vulgaris; Cochlearia
officinalis; Conium maculatium; Hydrastis canadensis; Matricaria
chamomilla; Nasturtium officinale; Phytolacca decendra; Pimpinella
saxifraga; Rhus toxicodendron; Scrophularia nodosa; Smilax medica;
Tussilago farfara; Veronica officinalis; and Vincetoxicum
officinale.
[0070] In one embodiment, the herbal preparation disclosed herein
comprises Mixture VI. Mixture VI comprises plant extracts obtained
from the following plants: Achillea millefolium; Aesuculus
hippocastanum; Althaea officinalis; Avena sativa; Conium
maculatium; Ervum lens; Hamamelis virginiana; Hydrastis canadensis;
Phytolacca decendra; Populas alba; Populus tremuloides; Sambucus
nigra; and Sanguinaria Canadensis.
[0071] In some embodiments, the herbal preparation disclosed herein
comprises a combination of Mixture I and Mixture II. In another
embodiment, the herbal preparation disclosed herein comprises a
combination of Mixture I and Mixture III. In another embodiment,
the herbal preparation disclosed herein comprises a combination of
Mixture I and Mixture IV.
[0072] In some embodiments, the herbal preparation disclosed herein
comprises a combination of Mixture II and Mixture III. In another
embodiment, the herbal preparation disclosed herein comprises a
combination of Mixture II and Mixture IV.
[0073] In some embodiments, the herbal preparation disclosed herein
comprises a combination of Mixture III and Mixture IV.
[0074] In some embodiments, the herbal preparation disclosed herein
comprises a combination of Mixture I, Mixture II and Mixture III.
In another embodiment, the herbal preparation disclosed herein
comprises a combination of Mixture I, Mixture II and Mixture IV. In
another embodiment, the herbal preparation disclosed herein
comprises a combination of Mixture I, Mixture III and Mixture IV.
In another embodiment, the herbal preparation disclosed herein
comprises a combination of Mixture II, Mixture III and Mixture
IV.
[0075] In another embodiment, the herbal preparation disclosed
herein comprises a combination of Mixture I, Mixture II, Mixture
III and Mixture IV.
[0076] In some embodiments, the herbal preparation disclosed herein
comprises a combination of Mixture V and Mixture VI.
[0077] In some embodiments the herbal preparations disclosed herein
comprise at least two herbal extracts each of which is selected
from the following list and each is present in the following amount
(w/w): Achillea millefolium from about 0.01% to about 20%;
Aesuculus hippocastanum from about 0.01% to about 20%; Althaea
officinalis from about 0.01% to about 20%; Avena sativa from about
0.01% to about 25%; Berberis vulgaris from about 0.01% to about
20%; Capsella Bursa Pastoris from about 0.01% to about 20%;
Cochlearia officinalis from about 0.01% to about 20%; Conium
maculatium from about 0.01% to about 35%; Ervum lens from about
0.01% to about 20%; Hamamelis virginiana from about 0.01% to about
25%; Hydrastis canadensis from about 0.01% to about 20%; Matricaria
chamomilla from about 0.01% to about 20%; Nasturtium officinale
from about 0.01% to about 15%; Phytolacca decendra from about 0.01%
to about 20%; Pimpinella saxifraga from about 0.01% to about 20%;
Populas alba from about 0.01% to about 20%; Populus tremuloides
from about 0.01% to about 20%; Rhus toxicodendron from about 0.01%
to about 25%; Sambucus nigra from about 0.01% to about 20;
Sanguinaria Canadensis from about 0.01% to about 20%; Scrophularia
nodosa from about 0.01% to about 20%; Smilax medica from about
0.01% to about 20%; Tussilago farfara from about 0.01% to about
15%; Veronica officinalis from about 0.01% to about 15%; and
Vincetoxicum officinale from about 0.01% to about 15%.
[0078] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts and at least one plant extract from the Group II plant
extracts, where the at least one Group I plant extract and the at
least one Group 11 plant extract are different.
[0079] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts and at least one plant extract from the Group III plant
extracts, where the at least one Group I plant extract and the at
least one Group III plant extract are different.
[0080] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts and at least one plant extract from the Group IV plant
extracts, where the at least one Group I plant extract and the at
least one Group IV plant extract are different.
[0081] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group 11 plant
extracts and at least one plant extract from the Group III plant
extracts, where the at least one Group 11 plant extract and the at
least one Group III plant extract are different.
[0082] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group 11 plant
extracts and at least one plant extract from the Group IV plant
extracts, where the at least one Group 11 plant extract and the at
least one Group IV plant extract are different.
[0083] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group III plant
extracts and at least one plant extract from the Group IV plant
extracts, where the at least one Group III plant extract and the at
least one Group IV plant extract are different.
[0084] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts, at least one plant extract from the Group II plant
extracts, and at least one plant extract from the Group III plant
extracts, where the at least one Group I plant extract, the at
least one Group II plant extract, and the at least one Group III
plant extract are different.
[0085] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts, at least one plant extract from the Group II plant
extracts, and at least one plant extract from the Group IV plant
extracts, where the at least one Group I plant extract, the at
least one Group II plant extract, and the at least one Group IV
plant extract are different.
[0086] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group I plant
extracts, at least one plant extract from the Group III plant
extracts, and at least one plant extract from the Group IV plant
extracts, where the at least one Group I plant extract, the at
least one Group III plant extract, and the at least one Group IV
plant extract are different.
[0087] In one embodiment, the herbal preparation disclosed herein
comprises at least one plant extract from the Group II plant
extracts, at least one plant extract from the Group III plant
extracts, and at least one plant extract from the Group IV plant
extracts, where the at least one Group II plant extract, the at
least one Group III plant extract, and the at least one Group IV
plant extract are different.
[0088] Group I comprises a plant extract obtained from a plant
selected from the group consisting of: Althaea officinalis; Ervum
lens; Populas alba; Populus tremuloides; Conium maculatium;
Sambucus nigra; Hamamelis virginiana; and Phytolacca decendra.
[0089] Group II comprises a plant extract obtained from a plant
selected from the group consisting of: Conium maculatium;
Phytolacca decendra; Pimpinella saxifraga; Rhus toxicodendron; and
Vincetoxicum officinale.
[0090] Group III comprises a plant extract obtained from a plant
selected from the group consisting of: Avena sativa; Aesuculus
hippocastanum; Capsella Bursa Pastoris; Hamamelis virginiana;
Hydrastis canadensis; Achillea millefolium; and Sanguinaria
Canadensis.
[0091] Group IV comprises a plant extract obtained from a plant
selected from the group consisting of: Berberis vulgaris;
Matricaria chamomilla; Cochlearia officinalis; Hydrastis
canadensis; Nasturtium officinale; Scrophularia nodosa; Smilax
medica; Tussilago farfara; and Veronica officinalis.
[0092] Thus, embodiments of the herbal extracts disclosed herein
include the mixtures numbered below in Table 1, comprising at least
two components, where the components are listed in Table 1.
TABLE-US-00001 TABLE 1 No. Component 1 Component 2 1 Achillea
millefolium from about 0.01% to Aesuculus hippocastanum from about
about 20% 0.01% to about 20% 2 Achillea millefolium from about
0.01% to Althaea officinalis from about 0.01% to about 20% about
20% 3 Achillea millefolium from about 0.01% to Avena sativa from
about 0.01% to about about 20% 25% 4 Achillea millefolium from
about 0.01% to Berberis vulgaris from about 0.01% to about 20%
about 20% 5 Achillea millefolium from about 0.01% to Cochlearia
officinalis from about 0.01% to about 20% about 20% 6 Achillea
millefolium from about 0.01% to Conium maculatium from about 0.01%
to about 20% about 35% 7 Achillea millefolium from about 0.01% to
Ervum lens from about 0.01% to about about 20% 20% 8 Achillea
millefolium from about 0.01% to Hamamelis virginiana from about
0.01% about 20% to about 25% 9 Achillea millefolium from about
0.01% to Hydrastis canadensis from about 0.01% to about 20% about
20% 10 Achillea millefolium from about 0.01% to Copsella Bursa
Pastoris from about 0.01% about 20% to about 20% 11 Achillea
millefolium from about 0.01% to Matricaria chamomilla from about
0.01% about 20% to about 20% 12 Achillea millefolium from about
0.01% to Nasturtium officinale from about 0.01% to about 20% about
15% 13 Achillea millefolium from about 0.01% to Phytolacca decendra
from about 0.01% to about 20% about 20% 14 Achillea millefolium
from about 0.01% to Pimpinella saxifraga from about 0.01% to about
20% about 20% 15 Achillea millefolium from about 0.01% to Populas
alba from about 0.01% to about about 20% 20% 16 Achillea
millefolium from about 0.01% to Populus tremuloides from about
0.01% to about 20% about 20% 17 Achillea millefolium from about
0.01% to Rhus toxicodendron from about 0.01% to about 20% about 25%
18 Achillea millefolium from about 0.01% to Sambucus nigra from
about 0.01% to about 20% about 20% 19 Achillea millefolium from
about 0.01% to Sanguinaria Canadensis from about 0.01% about 20% to
about 20% 20 Achillea millefolium from about 0.01% to Scrophularia
nodosa from about 0.01% to about 20% about 20% 21 Achillea
millefolium from about 0.01% to Smilax medica from about 0.01% to
about about 20% 20% 22 Achillea millefolium from about 0.01% to
Tussilago farfara from about 0.01% to about 20% about 15% 23
Achillea millefolium from about 0.01% to Veronica officinalis from
about 0.01% to about 20% about 15% 24 Achillea millefolium from
about 0.01% to Vincetoxicum officinale from about 0.01% about 20%
to about 15% 25 Aesuculus hippocastanum from about Althaea
officinalis from about 0.01% to 0.01% to about 20% about 20% 26
Aesuculus hippocastanum from about Avena sativa from about 0.01% to
about 0.01% to about 20% 25% 27 Aesuculus hippocastanum from about
Berberis vulgaris from about 0.01% to 0.01% to about 20% about 20%
28 Aesuculus hippocastanum from about Cochlearia officinalis from
about 0.01% to 0.01% to about 20% about 20% 29 Aesuculus
hippocastanum from about Conium maculatium from about 0.01% to
0.01% to about 20% about 35% 30 Aesuculus hippocastanum from about
Ervum lens from about 0.01% to about 0.01% to about 20% 20% 31
Aesuculus hippocastanum from about Hamamelis virginiana from about
0.01% 0.01% to about 20% to about 25% 32 Aesuculus hippocastanum
from about Hydrastis canadensis from about 0.01% to 0.01% to about
20% about 20% 33 Aesuculus hippocastanum from about Capsella Bursa
Pastoris from about 0.01% 0.01% to about 20% to about 20% 34
Aesuculus hippocastanum from about Matricaria chamomilla from about
0.01% 0.01% to about 20% to about 20% 35 Aesuculus hippocastanum
from about Nasturtium officinale from about 0.01% to 0.01% to about
20% about 15% 36 Aesuculus hippocastanum from about Phytolacca
decendra from about 0.01% to 0.01% to about 20% about 20% 37
Aesuculus hippocastanum from about Pimpinella saxifraga from about
0.01% to 0.01% to about 20% about 20% 38 Aesuculus hippocastanum
from about Populas alba from about 0.01% to about 0.01% to about
20% 20% 39 Aesuculus hippocastanum from about Populus tremuloides
from about 0.01% to 0.01% to about 20% about 20% 40 Aesuculus
hippocastanum from about Rhus toxicodendron from about 0.01% to
0.01% to about 20% about 25% 41 Aesuculus hippocastanum from about
Sambucus nigra from about 0.01% to 0.01% to about 20% about 20% 42
Aesuculus hippocastanum from about Sanguinaria Canadensis from
about 0.01% 0.01% to about 20% to about 20% 43 Aesuculus
hippocastanum from about Scrophularia nodosa from about 0.01% to
0.01% to about 20% about 20% 44 Aesuculus hippocastanum from about
Smilax medica from about 0.01% to about 0.01% to about 20% 20% 45
Aesuculus hippocastanum from about Tussilago farfara from about
0.01% to 0.01% to about 20% about 15% 46 Aesuculus hippocastanum
from about Veronica officinalis from about 0.01% to 0.01% to about
20% about 15% 47 Aesuculus hippocastanum from about Vincetoxicum
officinale from about 0.01% 0.01% to about 20% to about 15% 48
Althaea officinalis from about 0.01% to Avena sativa from about
0.01% to about about 20% 25% 49 Althaea officinalis from about
0.01% to Berberis vulgaris from about 0.01% to about 20% about 20%
50 Althaea officinalis from about 0.01% to Cochlearia officinalis
from about 0.01% to about 20% about 20% 51 Althaea officinalis from
about 0.01% to Conium maculatium from about 0.01% to about 20%
about 35% 52 Althaea officinalis from about 0.01% to Ervum lens
from about 0.01% to about about 20% 20% 53 Althaea officinalis from
about 0.01% to Hamamelis virginiana from about 0.01% about 20% to
about 25% 54 Althaea officinalis from about 0.01% to Hydrastis
canadensis from about 0.01% to about 20% about 20% 55 Althaea
officinalis from about 0.01% to Capsella Bursa Pastoris from about
0.01% about 20% to about 20% 56 Althaea officinalis from about
0.01% to Matricaria chamomilla from about 0.01% about 20% to about
20% 57 Althaea officinalis from about 0.01% to Nasturtium
officinale from about 0.01% to about 20% about 15% 58 Althaea
officinalis from about 0.01% to Phytolacca decendra from about
0.01% to about 20% about 20% 59 Althaea officinalis from about
0.01% to Pimpinella saxifraga from about 0.01% to about 20% about
20% 60 Althaea officinalis from about 0.01% to Populas alba from
about 0.01% to about about 20% 20% 61 Althaea officinalis from
about 0.01% to Populus tremuloides from about 0.01% to about 20%
about 20% 62 Althaea officinalis from about 0.01% to Rhus
toxicodendron from about 0.01% to about 20% about 25% 63 Althaea
officinalis from about 0.01% to Sambucus nigra from about 0.01% to
about 20% about 20% 64 Althaea officinalis from about 0.01% to
Sanguinaria Canadensis from about 0.01% about 20% to about 20% 65
Althaea officinalis from about 0.01% to Scrophularia nodosa from
about 0.01% to about 20% about 20% 66 Althaea officinalis from
about 0.01% to Smilax medica from about 0.01% to about about 20%
20% 67 Althaea officinalis from about 0.01% to Tussilago farfara
from about 0.01% to about 20% about 15% 68 Althaea officinalis from
about 0.01% to Veronica officinalis from about 0.01% to about 20%
about 15% 69 Althaea officinalis from about 0.01% to Vincetoxicum
officinale from about 0.01% about 20% to about 15% 70 Avena sativa
from about 0.01% to about Berberis vulgaris from about 0.01% to 25%
about 20% 71 Avena sativa from about 0.01% to about Cochlearia
officinalis from about 0.01% to 25% about 20% 72 Avena sativa from
about 0.01% to about Conium maculatium from about 0.01% to 25%
about 35% 73 Avena sativa from about 0.01% to about Ervum lens from
about 0.01% to about 25% 20% 74 Avena sativa from about 0.01% to
about Hamamelis virginiana from about 0.01% 25% to about 25% 75
Avena sativa from about 0.01% to about Hydrastis canadensis from
about 0.01% to 25% about 20% 76 Avena sativa from about 0.01% to
about Capsella Bursa Pastoris from about 0.01% 25% to about 20% 77
Avena sativa from about 0.01% to about Matricaria chamomilla from
about 0.01% 25% to about 20% 78 Avena sativa from about 0.01% to
about Nasturtium officinale from about 0.01% to 25% about 15% 79
Avena sativa from about 0.01% to about Phytolacca decendra from
about 0.01% to 25% about 20% 80 Avena sativa from about 0.01% to
about Pimpinella saxifraga from about 0.01% to 25% about 20% 81
Avena sativa from about 0.01% to about Populas alba from about
0.01% to about 25% 20% 82 Avena sativa from about 0.01% to about
Populus tremuloides from about 0.01% to 25% about 20%
83 Avena sativa from about 0.01% to about Rhus toxicodendron from
about 0.01% to 25% about 25% 84 Avena sativa from about 0.01% to
about Sambucus nigra from about 0.01% to 25% about 20% 85 Avena
sativa from about 0.01% to about Sanguinaria Canadensis from about
0.01% 25% to about 20% 86 Avena sativa from about 0.01% to about
Scrophularia nodosa from about 0.01% to 25% about 20% 87 Avena
sativa from about 0.01% to about Smilax medica from about 0.01% to
about 25% 20% 88 Avena sativa from about 0.01% to about Tussilago
farfara from about 0.01% to 25% about 15% 89 Avena sativa from
about 0.01% to about Veronica officinalis from about 0.01% to 25%
about 15% 90 Avena sativa from about 0.01% to about Vincetoxicum
officinale from about 0.01% 25% to about 15% 91 Berberis vulgaris
from about 0.01% to Cochlearia officinalis from about 0.01% to
about 20% about 20% 92 Berberis vulgaris from about 0.01% to Conium
maculatium from about 0.01% to about 20% about 35% 93 Berberis
vulgaris from about 0.01% to Ervum lens from about 0.01% to about
about 20% 20% 94 Berberis vulgaris from about 0.01% to Hamamelis
virginiana from about 0.01% about 20% to about 25% 95 Berberis
vulgaris from about 0.01% to Hydrastis canadensis from about 0.01%
to about 20% about 20% 96 Berberis vulgaris from about 0.01% to
Copsella Bursa Pastoris from about 0.01% about 20% to about 20% 97
Berberis vulgaris from about 0.01% to Matricaria chamomilla from
about 0.01% about 20% to about 20% 98 Berberis vulgaris from about
0.01% to Nasturtium officinale from about 0.01% to about 20% about
15% 99 Berberis vulgaris from about 0.01% to Phytolacca decendra
from about 0.01% to about 20% about 20% 100 Berberis vulgaris from
about 0.01% to Pimpinella saxifraga from about 0.01% to about 20%
about 20% 101 Berberis vulgaris from about 0.01% to Populas alba
from about 0.01% to about about 20% 20% 102 Berberis vulgaris from
about 0.01% to Populus tremuloides from about 0.01% to about 20%
about 20% 103 Berberis vulgaris from about 0.01% to Rhus
toxicodendron from about 0.01% to about 20% about 25% 104 Berberis
vulgaris from about 0.01% to Sambucus nigra from about 0.01% to
about 20% about 20% 105 Berberis vulgaris from about 0.01% to
Sanguinaria Canadensis from about 0.01% about 20% to about 20% 106
Berberis vulgaris from about 0.01% to Scrophularia nodosa from
about 0.01% to about 20% about 20% 107 Berberis vulgaris from about
0.01% to Smilax medica from about 0.01% to about about 20% 20% 108
Berberis vulgaris from about 0.01% to Tussilago farfara from about
0.01% to about 20% about 15% 109 Berberis vulgaris from about 0.01%
to Veronica officinalis from about 0.01% to about 20% about 15% 110
Berberis vulgaris from about 0.01% to Vincetoxicum officinale from
about 0.01% about 20% to about 15% 111 Cochlearia officinalis from
about 0.01% Conium maculatium from about 0.01% to to about 20%
about 35% 112 Cochlearia officinalis from about 0.01% Ervum lens
from about 0.01% to about to about 20% 20% 113 Cochlearia
officinalis from about 0.01% Hamamelis virginiana from about 0.01%
to about 20% to about 25% 114 Cochlearia officinalis from about
0.01% Hydrastis canadensis from about 0.01% to to about 20% about
20% 115 Cochlearia officinalis from about 0.01% Capsella Bursa
Pastoris from about 0.01% to about 20% to about 20% 116 Cochlearia
officinalis from about 0.01% Matricaria chamomilla from about 0.01%
to about 20% to about 20% 117 Cochlearia officinalis from about
0.01% Nasturtium officinale from about 0.01% to to about 20% about
15% 118 Cochlearia officinalis from about 0.01% Phytolacca decendra
from about 0.01% to to about 20% about 20% 119 Cochlearia
officinalis from about 0.01% Pimpinella saxifraga from about 0.01%
to to about 20% about 20% 120 Cochlearia officinalis from about
0.01% Populas alba from about 0.01% to about to about 20% 20% 121
Cochlearia officinalis from about 0.01% Populus tremuloides from
about 0.01% to to about 20% about 20% 122 Cochlearia officinalis
from about 0.01% Rhus toxicodendron from about 0.01% to to about
20% about 25% 123 Cochlearia officinalis from about 0.01% Sambucus
nigra from about 0.01% to to about 20% about 20% 124 Cochlearia
officinalis from about 0.01% Sanguinaria Canadensis from about
0.01% to about 20% to about 20% 125 Cochlearia officinalis from
about 0.01% Scrophularia nodosa from about 0.01% to to about 20%
about 20% 126 Cochlearia officinalis from about 0.01% Smilax medica
from about 0.01% to about to about 20% 20% 127 Cochlearia
officinalis from about 0.01% Tussilago farfara from about 0.01% to
to about 20% about 15% 128 Cochlearia officinalis from about 0.01%
Veronica officinalis from about 0.01% to to about 20% about 15% 129
Cochlearia officinalis from about 0.01% Vincetoxicum officinale
from about 0.01% to about 20% to about 15% 130 Conium maculatium
from about 0.01% Ervum lens from about 0.01% to about to about 35%
20% 131 Conium maculatium from about 0.01% Hamamelis virginiana
from about 0.01% to about 35% to about 25% 132 Conium maculatium
from about 0.01% Hydrastis canadensis from about 0.01% to to about
35% about 20% 133 Conium maculatium from about 0.01% Capsella Bursa
Pastoris from about 0.01% to about 35% to about 20% 134 Conium
maculatium from about 0.01% Matricaria chamomilla from about 0.01%
to about 35% to about 20% 135 Conium maculatium from about 0.01%
Nasturtium officinale from about 0.01% to to about 35% about 15%
136 Conium maculatium from about 0.01% Phytolacca decendra from
about 0.01% to to about 35% about 20% 137 Conium maculatium from
about 0.01% Pimpinella saxifraga from about 0.01% to to about 35%
about 20% 138 Conium maculatium from about 0.01% Populas alba from
about 0.01% to about to about 35% 20% 139 Conium maculatium from
about 0.01% Populus tremuloides from about 0.01% to to about 35%
about 20% 140 Conium maculatium from about 0.01% Rhus toxicodendron
from about 0.01% to to about 35% about 25% 141 Conium maculatium
from about 0.01% Sambucus nigra from about 0.01% to to about 35%
about 20% 142 Conium maculatium from about 0.01% Sanguinaria
Canadensis from about 0.01% to about 35% to about 20% 143 Conium
maculatium from about 0.01% Scrophularia nodosa from about 0.01% to
to about 35% about 20% 144 Conium maculatium from about 0.01%
Smilax medica from about 0.01% to about to about 35% 20% 145 Conium
maculatium from about 0.01% Tussilago farfara from about 0.01% to
to about 35% about 15% 146 Conium maculatium from about 0.01%
Veronica officinalis from about 0.01% to to about 35% about 15% 147
Conium maculatium from about 0.01% Vincetoxicum officinale from
about 0.01% to about 35% to about 15% 148 Ervum lens from about
0.01% to about Hamamelis virginiana from about 0.01% 20% to about
25% 149 Ervum lens from about 0.01% to about Hydrastis canadensis
from about 0.01% to 20% about 20% 150 Ervum lens from about 0.01%
to about Capsella Bursa Pastoris from about 0.01% 20% to about 20%
151 Ervum lens from about 0.01% to about Matricaria chamomilla from
about 0.01% 20% to about 20% 152 Ervum lens from about 0.01% to
about Nasturtium officinale from about 0.01% to 20% about 15% 153
Ervum lens from about 0.01% to about Phytolacca decendra from about
0.01% to 20% about 20% 154 Ervum lens from about 0.01% to about
Pimpinella saxifraga from about 0.01% to 20% about 20% 155 Ervum
lens from about 0.01% to about Populas alba from about 0.01% to
about 20% 20% 156 Ervum lens from about 0.01% to about Populus
tremuloides from about 0.01% to 20% about 20% 157 Ervum lens from
about 0.01% to about Rhus toxicodendron from about 0.01% to 20%
about 25% 158 Ervum lens from about 0.01% to about Sambucus nigra
from about 0.01% to 20% about 20% 159 Ervum lens from about 0.01%
to about Sanguinaria Canadensis from about 0.01% 20% to about 20%
160 Ervum lens from about 0.01% to about Scrophularia nodosa from
about 0.01% to 20% about 20% 161 Ervum lens from about 0.01% to
about Smilax medica from about 0.01% to about 20% 20% 162 Ervum
lens from about 0.01% to about Tussilago farfara from about 0.01%
to 20% about 15% 163 Ervum lens from about 0.01% to about Veronica
officinalis from about 0.01% to 20% about 15% 164 Ervum lens from
about 0.01% to about Vincetoxicum officinale from about 0.01% 20%
to about 15% 165 Hamamelis virginiana from about 0.01% Hydrastis
canadensis from about 0.01% to to about 25% about 20% 166 Hamamelis
virginiana from about 0.01% Capsella Bursa Pastoris from about
0.01% to about 25% to about 20%
167 Hamamelis virginiana from about 0.01% Matricaria chamomilla
from about 0.01% to about 25% to about 20% 168 Hamamelis virginiana
from about 0.01% Nasturtium officinale from about 0.01% to to about
25% about 15% 169 Hamamelis virginiana from about 0.01% Phytolacca
decendra from about 0.01% to to about 25% about 20% 170 Hamamelis
virginiana from about 0.01% Pimpinella saxifraga from about 0.01%
to to about 25% about 20% 171 Hamamelis virginiana from about 0.01%
Populas alba from about 0.01% to about to about 25% 20% 172
Hamamelis virginiana from about 0.01% Populus tremuloides from
about 0.01% to to about 25% about 20% 173 Hamamelis virginiana from
about 0.01% Rhus toxicodendron from about 0.01% to to about 25%
about 25% 174 Hamamelis virginiana from about 0.01% Sambucus nigra
from about 0.01% to to about 25% about 20% 175 Hamamelis virginiana
from about 0.01% Sanguinaria Canadensis from about 0.01% to about
25% to about 20% 176 Hamamelis virginiana from about 0.01%
Scrophularia nodosa from about 0.01% to to about 25% about 20% 177
Hamamelis virginiana from about 0.01% Smilax medica from about
0.01% to about to about 25% 20% 178 Hamamelis virginiana from about
0.01% Tussilago farfara from about 0.01% to to about 25% about 15%
179 Hamamelis virginiana from about 0.01% Veronica officinalis from
about 0.01% to to about 25% about 15% 180 Hamamelis virginiana from
about 0.01% Vincetoxicum officinale from about 0.01% to about 25%
to about 15% 181 Hydrastis canadensis from about 0.01% Capsella
Bursa Pastoris from about 0.01% to about 20% to about 20% 182
Hydrastis canadensis from about 0.01% Matricaria chamomilla from
about 0.01% to about 20% to about 20% 183 Hydrastis canadensis from
about 0.01% Nasturtium officinale from about 0.01% to to about 20%
about 15% 184 Hydrastis canadensis from about 0.01% Phytolacca
decendra from about 0.01% to to about 20% about 20% 185 Hydrastis
canadensis from about 0.01% Pimpinella saxifraga from about 0.01%
to to about 20% about 20% 186 Hydrastis canadensis from about 0.01%
Populas alba from about 0.01% to about to about 20% 20% 187
Hydrastis canadensis from about 0.01% Populus tremuloides from
about 0.01% to to about 20% about 20% 188 Hydrastis canadensis from
about 0.01% Rhus toxicodendron from about 0.01% to to about 20%
about 25% 189 Hydrastis canadensis from about 0.01% Sambucus nigra
from about 0.01% to to about 20% about 20% 190 Hydrastis canadensis
from about 0.01% Sanguinaria Canadensis from about 0.01% to about
20% to about 20% 191 Hydrastis canadensis from about 0.01%
Scrophularia nodosa from about 0.01% to to about 20% about 20% 192
Hydrastis canadensis from about 0.01% Smilax medica from about
0.01% to about to about 20% 20% 193 Hydrastis canadensis from about
0.01% Tussilago farfara from about 0.01% to to about 20% about 15%
194 Hydrastis canadensis from about 0.01% Veronica officinalis from
about 0.01% to to about 20% about 15% 195 Hydrastis canadensis from
about 0.01% Vincetoxicum officinale from about 0.01% to about 20%
to about 15% 196 Capsella Bursa Pastoris from about Matricaria
chamomilla from about 0.01% 0.01% to about 20% to about 20% 197
Capsella Bursa Pastoris from about Nasturtium officinale from about
0.01% to 0.01% to about 20% about 15% 198 Capsella Bursa Pastoris
from about Phytolacca decendra from about 0.01% to 0.01% to about
20% about 20% 199 Capsella Bursa Pastoris from about Pimpinella
saxifraga from about 0.01% to 0.01% to about 20% about 20% 200
Capsella Bursa Pastoris from about Populas alba from about 0.01% to
about 0.01% to about 20% 20% 201 Capsella Bursa Pastoris from about
Populus tremuloides from about 0.01% to 0.01% to about 20% about
20% 202 Capsella Bursa Pastoris from about Rhus toxicodendron from
about 0.01% to 0.01% to about 20% about 25% 203 Capsella Bursa
Pastoris from about Sambucus nigra from about 0.01% to 0.01% to
about 20% about 20% 204 Capsella Bursa Pastoris from about
Sanguinaria Canadensis from about 0.01% 0.01% to about 20% to about
20% 205 Capsella Bursa Pastoris from about Scrophularia nodosa from
about 0.01% to 0.01% to about 20% about 20% 206 Capsella Bursa
Pastoris from about Smilax medica from about 0.01% to about 0.01%
to about 20% 20% 207 Capsella Bursa Pastoris from about Tussilago
farfara from about 0.01% to 0.01% to about 20% about 15% 208
Capsella Bursa Pastoris from about Veronica officinalis from about
0.01% to 0.01% to about 20% about 15% 209 Capsella Bursa Pastoris
from about Vincetoxicum officinale from about 0.01% 0.01% to about
20% to about 15% 210 Matricaria chamomilla from about Nasturtium
officinale from about 0.01% to 0.01% to about 20% about 15% 211
Matricaria chamomilla from about Phytolacca decendra from about
0.01% to 0.01% to about 20% about 20% 212 Matricaria chamomilla
from about Pimpinella saxifraga from about 0.01% to 0.01% to about
20% about 20% 213 Matricaria chamomilla from about Populas alba
from about 0.01% to about 0.01% to about 20% 20% 214 Matricaria
chamomilla from about Populus tremuloides from about 0.01% to 0.01%
to about 20% about 20% 215 Matricaria chamomilla from about Rhus
toxicodendron from about 0.01% to 0.01% to about 20% about 25% 216
Matricaria chamomilla from about Sambucus nigra from about 0.01% to
0.01% to about 20% about 20% 217 Matricaria chamomilla from about
Sanguinaria Canadensis from about 0.01% 0.01% to about 20% to about
20% 218 Matricaria chamomilla from about Scrophularia nodosa from
about 0.01% to 0.01% to about 20% about 20% 219 Matricaria
chamomilla from about Smilax medica from about 0.01% to about 0.01%
to about 20% 20% 220 Matricaria chamomilla from about Tussilago
farfara from about 0.01% to 0.01% to about 20% about 15% 221
Matricaria chamomilla from about Veronica officinalis from about
0.01% to 0.01% to about 20% about 15% 222 Matricaria chamomilla
from about Vincetoxicum officinale from about 0.01% 0.01% to about
20% to about 15% 223 Nasturtium officinale from about 0.01%
Phytolacca decendra from about 0.01% to to about 15% about 20% 224
Nasturtium officinale from about 0.01% Pimpinella saxifraga from
about 0.01% to to about 15% about 20% 225 Nasturtium officinale
from about 0.01% Populas alba from about 0.01% to about to about
15% 20% 226 Nasturtium officinale from about 0.01% Populus
tremuloides from about 0.01% to to about 15% about 20% 227
Nasturtium officinale from about 0.01% Rhus toxicodendron from
about 0.01% to to about 15% about 25% 228 Nasturtium officinale
from about 0.01% Sambucus nigra from about 0.01% to to about 15%
about 20% 229 Nasturtium officinale from about 0.01% Sanguinaria
Canadensis from about 0.01% to about 15% to about 20% 230
Nasturtium officinale from about 0.01% Scrophularia nodosa from
about 0.01% to to about 15% about 20% 231 Nasturtium officinale
from about 0.01% Smilax medica from about 0.01% to about to about
15% 20% 232 Nasturtium officinale from about 0.01% Tussilago
farfara from about 0.01% to to about 15% about 15% 233 Nasturtium
officinale from about 0.01% Veronica officinalis from about 0.01%
to to about 15% about 15% 234 Nasturtium officinale from about
0.01% Vincetoxicum officinale from about 0.01% to about 15% to
about 15% 235 Phytolacca decendra from about 0.01% Pimpinella
saxifraga from about 0.01% to to about 20% about 20% 236 Phytolacca
decendra from about 0.01% Populas alba from about 0.01% to about to
about 20% 20% 237 Phytolacca decendra from about 0.01% Populus
tremuloides from about 0.01% to to about 20% about 20% 238
Phytolacca decendra from about 0.01% Rhus toxicodendron from about
0.01% to to about 20% about 25% 239 Phytolacca decendra from about
0.01% Sambucus nigra from about 0.01% to to about 20% about 20% 240
Phytolacca decendra from about 0.01% Sanguinaria Canadensis from
about 0.01% to about 20% to about 20% 241 Phytolacca decendra from
about 0.01% Scrophularia nodosa from about 0.01% to to about 20%
about 20% 242 Phytolacca decendra from about 0.01% Smilax medica
from about 0.01% to about to about 20% 20% 243 Phytolacca decendra
from about 0.01% Tussilago farfara from about 0.01% to to about 20%
about 15% 244 Phytolacca decendra from about 0.01% Veronica
officinalis from about 0.01% to to about 20% about 15% 245
Phytolacca decendra from about 0.01% Vincetoxicum officinale from
about 0.01% to about 20% to about 15% 246 Pimpinella saxifraga from
about 0.01% Populas alba from about 0.01% to about to about 20% 20%
247 Pimpinella saxifraga from about 0.01% Populus tremuloides from
about 0.01% to to about 20% about 20% 248 Pimpinella saxifraga from
about 0.01% Rhus toxicodendron from about 0.01% to to about 20%
about 25% 249 Pimpinella saxifraga from about 0.01% Sambucus nigra
from about 0.01% to to about 20% about 20% 250 Pimpinella saxifraga
from about 0.01% Sanguinaria Canadensis from about 0.01% to about
20% to about 20% 251 Pimpinella saxifraga from about 0.01%
Scrophularia nodosa from about
0.01% to to about 20% about 20% 252 Pimpinella saxifraga from about
0.01% Smilax medica from about 0.01% to about to about 20% 20% 253
Pimpinella saxifraga from about 0.01% Tussilago farfara from about
0.01% to to about 20% about 15% 254 Pimpinella saxifraga from about
0.01% Veronica officinalis from about 0.01% to to about 20% about
15% 255 Pimpinella saxifraga from about 0.01% Vincetoxicum
officinale from about 0.01% to about 20% to about 15% 256 Populas
alba from about 0.01% to about Populus tremuloides from about 0.01%
to 20% about 20% 257 Populas alba from about 0.01% to about Rhus
toxicodendron from about 0.01% to 20% about 25% 258 Populas alba
from about 0.01% to about Sambucus nigra from about 0.01% to 20%
about 20% 259 Populas alba from about 0.01% to about Sanguinaria
Canadensis from about 0.01% 20% to about 20% 260 Populas alba from
about 0.01% to about Scrophularia nodosa from about 0.01% to 20%
about 20% 261 Populas alba from about 0.01% to about Smilax medica
from about 0.01% to about 20% 20% 262 Populas alba from about 0.01%
to about Tussilago farfara from about 0.01% to 20% about 15% 263
Populas alba from about 0.01% to about Veronica officinalis from
about 0.01% to 20% about 15% 264 Populas alba from about 0.01% to
about Vincetoxicum officinale from about 0.01% 20% to about 15% 265
Populus tremuloides from about 0.01% Rhus toxicodendron from about
0.01% to to about 20% about 25% 266 Populus tremuloides from about
0.01% Sambucus nigra from about 0.01% to to about 20% about 20% 267
Populus tremuloides from about 0.01% Sanguinaria Canadensis from
about 0.01% to about 20% to about 20% 268 Populus tremuloides from
about 0.01% Scrophularia nodosa from about 0.01% to to about 20%
about 20% 269 Populus tremuloides from about 0.01% Smilax medica
from about 0.01% to about to about 20% 20% 270 Populus tremuloides
from about 0.01% Tussilago farfara from about 0.01% to to about 20%
about 15% 271 Populus tremuloides from about 0.01% Veronica
officinalis from about 0.01% to to about 20% about 15% 272 Populus
tremuloides from about 0.01% Vincetoxicum officinale from about
0.01% to about 20% to about 15% 273 Rhus toxicodendron from about
0.01% to Sambucus nigra from about 0.01% to about 25% about 20% 274
Rhus toxicodendron from about 0.01% to Sanguinaria Canadensis from
about 0.01% about 25% to about 20% 275 Rhus toxicodendron from
about 0.01% to Scrophularia nodosa from about 0.01% to about 25%
about 20% 276 Rhus toxicodendron from about 0.01% to Smilax medica
from about 0.01% to about about 25% 20% 277 Rhus toxicodendron from
about 0.01% to Tussilago farfara from about 0.01% to about 25%
about 15% 278 Rhus toxicodendron from about 0.01% to Veronica
officinalis from about 0.01% to about 25% about 15% 279 Rhus
toxicodendron from about 0.01% to Vincetoxicum officinale from
about 0.01% about 25% to about 15% 280 Sambucus nigra from about
0.01% to Sanguinaria Canadensis from about 0.01% about 20% to about
20% 281 Sambucus nigra from about 0.01% to Scrophularia nodosa from
about 0.01% to about 20% about 20% 282 Sambucus nigra from about
0.01% to Smilax medica from about 0.01% to about about 20% 20% 283
Sambucus nigra from about 0.01% to Tussilago farfara from about
0.01% to about 20% about 15% 284 Sambucus nigra from about 0.01% to
Veronica officinalis from about 0.01% to about 20% about 15% 285
Sambucus nigra from about 0.01% to Vincetoxicum officinale from
about 0.01% about 20% to about 15% 286 Sanguinaria Canadensis from
about Scrophularia nodosa from about 0.01% to 0.01% to about 20%
about 20% 287 Sanguinaria Canadensis from about Smilax medica from
about 0.01% to about 0.01% to about 20% 20% 288 Sanguinaria
Canadensis from about Tussilago farfara from about 0.01% to 0.01%
to about 20% about 15% 289 Sanguinaria Canadensis from about
Veronica officinalis from about 0.01% to 0.01% to about 20% about
15% 290 Sanguinaria Canadensis from about Vincetoxicum officinale
from about 0.01% 0.01% to about 20% to about 15% 291 Scrophularia
nodosa from about 0.01% Smilax medica from about 0.01% to about to
about 20% 20% 292 Scrophularia nodosa from about 0.01% Tussilago
farfara from about 0.01% to to about 20% about 15% 293 Scrophularia
nodosa from about 0.01% Veronica officinalis from about 0.01% to to
about 20% about 15% 294 Scrophularia nodosa from about 0.01%
Vincetoxicum officinale from about 0.01% to about 20% to about 15%
295 Smilax medica from about 0.01% to Tussilago farfara from about
0.01% to about 20% about 15% 296 Smilax medica from about 0.01% to
Veronica officinalis from about 0.01% to about 20% about 15% 297
Smilax medica from about 0.01% to Vincetoxicum officinale from
about 0.01% about 20% to about 15% 298 Tussilago farfara from about
0.01% to Veronica officinalis from about 0.01% to about 15% about
15% 299 Tussilago farfara from about 0.01% to Vincetoxicum
officinale from about 0.01% about 15% to about 15% 300 Veronica
officinalis from about 0.01% to Vincetoxicum officinale from about
0.01% about 15% to about 15%
[0093] In another non-limiting aspect, disclosed herein are
processes for obtaining a plant extract, the process comprising the
step of a) mixing the plant with water and/or another solvent, b)
distilling the mixture, and c) collecting the distillate.
[0094] In some embodiments, the process further comprises the step
of d) separating the aqueous phase from the oil phase and
collecting the aqueous phase, after step c).
[0095] In some embodiments, the process further comprises the step
of e) adding more of the plant to the aqueous phase and fermenting
the mixture, after step c) or after step d).
[0096] In some embodiments, the process further comprises the step
of f) distilling the fermented mixture and collecting the
distillate, after step e).
[0097] In some embodiments, the process further comprises the steps
of g) heating the remaining plant material until most of the
moisture has evaporated, after step f), and h) extracting the water
soluble salts or hygroscopic salts from the dried plant material.
In some embodiments, the remaining plant material is not completely
dry. In other embodiments, the remaining plant material is
completely dry. In further embodiments, the remaining plant
material begins to char. In yet other embodiments, the remaining
plant material begins to incinerate.
[0098] In some embodiments, the process further comprises the step
of i) adding the distillate of step e) to the extracted salts of
step h).
[0099] In another non-limiting aspect, disclosed herein are herbal
extractions obtained by the above process.
[0100] When afflicted with an epidermal condition, the human skin
naturally works to alleviate the symptoms of the condition. For
example, in most cases, redness, itching, or scaling due to some
disorders improve over time, or until the next episode of a flare
up. The herbal preparations disclosed herein help the skin in its
natural course to reduce the adverse symptoms. Without being bound
to a particular theory, the present inventors believe that the
present herbal preparations provide the skin with the nutrients and
building blocks necessary to efficiently and effectively work to
reduce the symptoms.
[0101] Thus, in another non-limiting aspect, disclosed herein are
methods of reducing symptoms associated with a skin condition in a
subject, comprising identifying the subject in need thereof and
administering to the subject an effective amount of an herbal
preparation as disclosed herein.
[0102] In some embodiments, the symptoms associated with a skin
condition include, but are not limited to, redness, itching,
scaling, flaking, dry skin, acne, and the like associated with
disorders such as acne vulgaris, psoriasis, eczema, or atopic
dermatitis. In certain embodiments, the skin symptom is pruritis
(itching), erythema (redness), or excoriations (flaking).
[0103] The term "subject" refers to an animal, such as (but not
limited to) a mammal, and more particularly (but not by way of
limitation) a human, who is the object of treatment, observation or
experiment. The mammal may be selected from the group consisting of
mice, rats, rabbits, guinea pigs, dogs, cats, sheep, goats, cows,
primates, such as monkeys, chimpanzees, and apes, and humans.
[0104] The term "effective amount" or "therapeutically effective
amount" is used to indicate an amount of an herbal preparation that
elicits the biological response indicated. This response may occur
in a tissue, system, animal or human and includes alleviation of
the symptoms being treated.
[0105] In another non-limiting aspect, disclosed herein are
compositions comprising the herbal preparations disclosed herein
and at least one physiologically acceptable excipient, diluent, or
carrier.
[0106] The term "excipient" refers to a substance added to the
compositions disclosed herein. In some cases, the herbal
preparations disclosed herein may not by itself be easily
administered and/or absorbed by the subject. In these cases the
herbal preparations may be dissolved into or mixed with an
excipient. Excipients are also sometimes used to bulk up
formulations that contain the herbal preparations, to allow for
convenient and accurate application. In addition to their use in
the single application quantity, excipients can be used in the
manufacturing process to aid in the handling of the herbal
preparations concerned. Excipients also aid in stabilizing the
formulations of the herbal preparations, for example by keeping the
various ingredients in solution or in suspension, preventing
precipitation or crystallization, or adherence to container
walls.
[0107] The term "carrier" defines a chemical compound that
facilitates the incorporation of a compound into cells or tissues.
For example, dimethyl sulfoxide (DMSO) is a commonly utilized
carrier as it facilitates the uptake of many organic compounds into
the cells or tissues of a subject.
[0108] The term "diluent" defines chemical compounds diluted in
water that will dissolve the herbal extracts of interest and/or
stabilize the formulation of the herbal preparations, including
shelf life. Salts dissolved in buffered solutions are utilized as
diluents in the art. One commonly used buffered solution is
phosphate buffered saline because it mimics the salt conditions of
human blood. Since buffer salts can control the pH of a solution at
low concentrations, a buffered diluent rarely modifies the benefit
of the herbal preparation.
[0109] Accordingly, disclosed herein are compositions and methods
for the alleviation of the symptoms of skin conditions. The herbal
preparations of the present disclosure can be delivered or
administered to a mammal, (e.g., human subject), alone, or in the
form of a formulated composition wherein the herbal preparation is
mixed with suitable carriers or excipient(s) in an effective
amount.
[0110] The herbal preparations that are used in the methods
disclosed herein can be administered as formulated compositions
comprising the herbal preparation together with one or more other
physiologically acceptable component. Compositions can be in the
form of solids (i.e., powders, granules, dragees, tablets, or
pills), semi-solids (i.e., gels, slurries, or ointments), or
liquids.
[0111] Suitable routes of administration may, for example, include
oral, topical, rectal, transmucosal, epidural, vaginal,
transdermal, or buccal administration.
[0112] Suitable formulations for use in the present disclosure are
found in, for example, Remington's Pharmaceutical Sciences, Mack
Publishing Company, Philadelphia, Pa., 17th ed. (1985) and Langer,
Science, 249:1527-1533 (1990). The compositions described herein
can be manufactured in a conventional manner, e.g., mixing,
dissolving, granulating, dragee-making, levigating, emulsifying,
encapsulating, entrapping, or lyophilizing processes.
[0113] The herbal preparations can be formulated with common
excipients, diluents or carriers, and compressed into tablets, or
formulated as elixirs or solutions for convenient oral
administration. The agents can also be formulated as sustained
release dosage forms and the like.
[0114] The compositions disclosed herein may be manufactured in a
manner that is itself known, e.g., by means of conventional mixing,
dissolving, granulating, dragee-making, levigating, emulsifying,
encapsulating, entrapping or tabletting processes.
[0115] Compositions for use in accordance with the present
disclosure thus may be formulated in a conventional manner using
one or more physiologically acceptable carriers comprising
excipients and auxiliaries, which facilitate processing of the
herbal extracts into herbal preparations. Proper formulation is
dependent upon the route of administration chosen. Any of the
well-known techniques, carriers, and excipients may be used as
suitable and as understood in the art; e.g., in Remington's
Pharmaceutical Sciences, above.
[0116] For transmucosal administration, penetrants appropriate to
the barrier to be permeated are used in the formulation. Such
penetrants are generally known in the art.
[0117] Compositions suitable for use in accordance with the present
disclosure include compositions wherein the herbal preparations are
contained in an effective amount. The effective amounts for the
methods of the present disclosure can depend on a variety of
factors, including, e.g., age, body weight, general health, sex,
diet, time and manner of administration, and the severity of the
particular affliction being treated.
EXAMPLES
Example 1: Herb Extraction
[0118] Procedure A:
[0119] Herb extraction was achieved by steam distillation.
Optionally, one or more of the steps of oil separation,
fermentation, hygroscopic salt extraction, and cohobation was added
to the steam distillation step. The procedures were as follows.
[0120] Steam Distillation
[0121] Three liters of deionized water was poured into a 5 L
distillation apparatus flask, which was then placed on a sand bath.
Herb was added to the distillation apparatus flask until the flask
was about half full. A filter paper was placed at the joint of the
distillation apparatus before hooking up the reaction head adaptor.
A 2 L receiving flask was used. Low heat was provided, sufficient
for steam to cloud the distillation apparatus and adapter. After
1.5 L of distillate was collected, the heat was turned off and the
apparatus was allowed to cool. The distillate was removed. One
liter of deionized water was added to the distillation apparatus
flask and the distillation was repeated. The distillation was
repeated three times.
[0122] Oil Separation
[0123] The distillate, containing an aqueous phase and an oil
phase, was transferred into a foil drain tube. The stopcock at the
end of the drain tube was opened and the water was drained off into
a 5 L flask.
[0124] Fermentation
[0125] Herb was placed into the 5 L flask containing the water
after oil separation. The flask was sealed using a secure
fermentation lock, and was incubated at 27.degree. C. for two
weeks. Subsequently, the waterwas distilled 5 times and the
distillate was saved in a separate container.
[0126] Hygroscopic Salt Extraction
[0127] The remaining plant material was boiled until the moisture
was evaporated and the plant material began to incinerate. Once the
incinerated plant material became grey, it was removed from heat
and allowed to cool. A Soxhlet extractor was used to extract the
water soluble salts from the incinerated plant material. The salts
were isolated by rotary evaporation. The extracted salts were
placed in a calcining kiln at 600.degree. C. for 1 week. The
process was repeated for a total of 3 times.
[0128] Cohobation
[0129] The solution obtained after fermentation and the volatile
oils were added to the isolated salts. The mixture was incubated at
30.degree. C. for 1 week. The herbal-medicinal concentrate was
separated without disturbing the sediment. The concentrate can be
diluted as needed.
[0130] Procedure B:
[0131] Each individual plant raw material was subjected to steam
distillation. After distillation the leftover material was in the
form of wet mass. Additional water was added and the mixture was
allowed to ferment in a glass container covered with a cloth lid.
Fermentation was continued for 7 days at room temperature. During
the fermentation the pH was monitored. Fermentation was allowed to
continue until the mixtures began to putrefy. After the
fermentation was over the biomass was filtered through a cloth
filter and was subjected to distillation at 80-90.degree. C. to get
30-40% of distillate of filtrate.
[0132] The leftover biomass was transferred to trays made from
GI/MS and covered with cloth and was kept for drying in the shade.
The drying was continued until the biomass became crisp dry, i.e.,
for about 15-20 days. During this time the material was turned
around once in a day. After drying the material was subjected to
ashing by either 1) burning the dry mass and collecting the cooled
ash, which was then transferred to a crucible and heated further in
an oven, or 2) incinerating the biomass by heating in a crucible at
600.degree. C. The ash obtained is dissolved in distilled water and
subjected to further distillation. All distillates were combined
together and subjected to cohobation, where the combined product is
heated under reflux for some time.
Example 2: Herbal Preparations
[0133] For the experiments detailed below, a unique herbal
preparation (HAT-01) was used. Table 2 shows the herbs and their
weight percentages within this formulation.
TABLE-US-00002 TABLE 2 Composition of HAT-01 Percentage Genus
Species Common Name Composition Conium maculatum Hemlock 12.1
Hamamelis virginiana Witch hazel 8.9 Rhus toxicodendron Ivy 8.3
Avena sativa Oat 6.8 Hydrastis canadensis Orange root 6.0
Phytolacca decandra Poke root 5.8 Cochlearia officinalis Scurvy
grass 5.1 Populus alba White Poplar 4.9 Populus tremuloides Quaking
Aspen 4.8 Sanguinaria canadensis Blood root 4.5 Berberis vulgaris
Barberry 4.1 Scrophularia nodosa Figwort 4.0 Ervum lens Lentil 3.7
Smilax medica Sarsaparilla 3.1 Achillea millefolium Yarrow 2.5
Aesculus hippocastanum Horsechestnut 2.4 Capsella Bursa Pastoris
Shepherd's Purse 2.3 Matricaria chamomilla Chamomile 2.2 Althaea
officinalis Mallow 2.0 Sambucus nigra Elderberry 1.9 Pimpinella
saxifraga Burnet 1.1 Vincetoxicum officinale Swallow wort 0.9
Nasturtium officinale Watercress 0.9 Tussilago farfara Colts foot
0.9 Veronica officinalis Speedwell 0.8 Total 100
[0134] Furthermore, to compare constituent efficacy and synergism,
HAT-01 was also partially formulated into two: HAT-01:P1 and
HAT-01:P2 as described in Tables 3 and 4, respectively. These herbs
have established clinical benefit, and are considered safe for
clinical use in chronic inflammatory conditions.
TABLE-US-00003 TABLE 3 Composition of HAT-01:P1 Percentage Genus
Species Composition Conium maculatum 21 Rhus toxicodendron 17
Cochlearia officinalis 10 Hydrastis canadensis 8 Phytolacca
decandra 8 Berberis vulgaris 8 Scrophularia nodosa 8 Smilax medica
6 Matricaria chamomilla 4 Pimpinella saxifraga 2 Vincetoxicum
officinale 2 Nasturtium officinale 2 Tussilago farfara 2 Veronica
officinalis 2 Total 100
TABLE-US-00004 TABLE 4 Composition of HAT-01:P2 Percentage Genus
Species Composition Hamamelis virginiana 13 Avena sativa 14 Populus
alba 10 Populus tremuloides 10 Sanguinaria canadensis 9 Ervum lens
8 Achillea millefolium 5 Aesculus hippocastanum 5 Hydrastis
canadensis 5 Capsella Bursa Pastoris 5 Althaea officinalis 4 Conium
maculatum 4 Phytolacca decandra 4 Sambucus nigra 4 Total 100
[0135] Our NMR analyses of the ingredients in HAT-01 have confirmed
the relative concentrations of components, and absolute
concentrations of known substances. Of note, results from 1H-NMR
spectroscopic analyses of HAT-01 showed no evidence of a
corticosteroid moiety, which correlates well with our findings that
no changes were observed in serum cortisol levels in mice before
and after treatment with 10% oral HAT-01, and demonstrating that
HAT-01 effects are nonsteroidal.
Example 3: Benefits of HAT-01 in Patients with Psoriasis: Pilot
Trial
[0136] To assess the benefits of HAT-01 in psoriasis, we performed
an 8-week, open-label, two armed study (HAT-01 and OTC medication
arm) in patients with mild to moderate chronic plaque psoriasis.
Patients (aged 18 to 70 years) with stable chronic plaque psoriasis
of at least 6 months duration with a psoriasis body surface area
(BSA) 10% were included. All areas with the exception of the face,
groin and axillae were treated. Patients with current or recent
malignancies, severe asthma, infections, uncontrolled hypertension,
and/or those treated with systemic or topical corticosteroid or
immunosuppressant agents were excluded from the study. Patients
with abnormal screening laboratory values, as well as pregnant
women, were also excluded from the study. Patients were not allowed
to use any medicated cosmetics that might influence the outcome of
the study. A total of 16 patients fulfilling psoriasis inclusion
criteria were enrolled into an exploratory 8 week, open-label study
designed to investigate the safety, utility and tolerability of
HAT-01. Patients were enrolled into one of two arms: (a)
twice-daily application of HAT-01 (n=9 patients) or (b) twice-daily
application of over-the-counter topical medications which are
first-line therapy for patients with psoriasis and included topical
vitamin D.sub.3 analog calcipotriene or topical retinoids (n=7
patients). Approximately 300 .mu.l of HAT-01 was applied per
lesion, prepared as a 10% dilution of the concentrated herbal
extracts in 4.9% EtOH. The primary outcome was defined as the
percentage change from baseline in the body surface area affected
by psoriasis at weeks 2, 4, and 8 following treatment. Safety
evaluations included tolerability assessments and incidence of
adverse events.
[0137] Patients were evaluated for changes in total body surface
area, erythema, scaling, and plaque resolution. Patients with
moderate disease activity who received HAT-01 demonstrated an
average 42% reduction in the percentage in body surface area
affected by psoriasis at 8 weeks, whereas those treated with a
control OTC topical vitamin D.sub.3 analog calcipotriene and
topical retinoids exhibited a reduction in the percentage in body
surface area affected by psoriasis by only 12% (FIG. 1).
Significant resolution in erythema and scaling with changes in
plaque elevation (from that of marked to slight) was observed in 8
of 9 patients after 8 weeks of HAT-01 treatment.
[0138] HAT-01 was well tolerated, with no treatment-related adverse
events observed throughout the 8-week trial. At week 8, all
patients treated with HAT-01 had no reports of skin atrophy,
pruritus, or burning/stinging. In contrast at 8 weeks of treatment,
4 of 7 patients that were treated with control OTC topical vitamin
D.sub.3 analog calcipotriene exhibited local treatment-site
irritation, burning sensation, and pain.
Example 4: Therapeutic Effects of HAT-01 in Patients with Acne
Vulgaris: Clinical Vignettes
[0139] To assess the effects of HAT-01 in acne vulgaris, an
open-label study of HAT-01 in subjects with mild to moderate (grade
I and II) acne vulgaris was undertaken at an outpatient setting of
a private practice clinic. Subjects aged 18 to 50 years of age with
>three inflammatory or non-inflammatory lesions of papules or
pustules in the face were included. Exclusion criteria included:
severe acne, the use of any anti-acne medications within the
preceding four weeks, or subjects with cystic lesions or any acne
requiring systemic treatment. Subjects were not allowed to use any
medicated cosmetics that might influence the outcome of the study.
A total of 4 patients fulfilling criteria were enrolled. The
primary efficacy outcome was defined as the change from baseline of
the total lesion count. Subjects were asked to follow a 4 week
regimen of twice daily applications of HAT-01 (300 .mu.l applied
per lesion, prepared as a 10% dilution of the concentrated herbal
extracts in 4.9% EtOH). An analysis of the post-treatment
inflammatory and non-inflammatory lesion counts demonstrated a
highly significant reduction of scores from baseline to 4 week time
points, indicative of the therapeutic potential of HAT-01 in acne
vulgaris. HAT-01 was well tolerated, with no treatment-related
adverse events observed throughout the 4-week trial including no
reports of skin atrophy, pruritus, or burning/stinging at the local
treatment-site.
Example 5: Clinical Studies
[0140] Methodology
[0141] The clinical trial was conducted in a contract research
organization setting with three investigators (dermatologists) in a
multi-center site. Patients were block randomized from a central
location into each study arm. Patients were assessed both before
and throughout the course of treatment at each visit using by
SCORAD and a Patient Benefit Index (which assesses AD
patient-relevant treatment benefit). SCORAD values, ranging from 0
to 103, are classified as mild (<15), moderate (16-40) and
severe (>41), and are calculated as
(0.2.times.Area)+(3.5.times.Erythema+Edema+Crust+Excoriation+Lichenificat-
ion+Dryness)+(pruritis+sleep loss). All three investigators were
given prior training and testing for standardized scoring of SCORAD
in AD, an approach that has been found to be significantly
beneficial for minimizing observer variability.
[0142] Our primary objective was the efficacy of HAT-01, HAT-01P1,
and/or HAT-01P2 in the reduction of pruritus in atopic dermatitis
patients.
[0143] Our secondary objective(s) were to
[0144] evaluate the therapeutic benefit of HAT-01, HAT-01P1, and/or
HAT-01P2 in atopic dermatitis as measured by the SCORAD (SCORing
Atopic Dermatitis),
[0145] evaluate the therapeutic benefit of HAT-01, HAT-01P1, and/or
HAT-01P2 to reduce pruritus from patient's perspective as assessed
by the Patient Benefit Index, and
[0146] safety and tolerability of HAT-01, HAT-01P1, and/or HAT-01P2
in atopic dermatitis patients.
[0147] Double Blinded Randomization: A double blind approach where
both investigators and patients are blinded was used. Investigators
performed enrollment and blinded assignment using blinded labels.
Assignments were rotated through enrollment by investigators to
enable random continuous enrollment and avoid selection bias.
[0148] Treatment: Atopic dermatitis patients fulfilling eligibility
(inclusion and exclusion criteria) were provided with an informed
consent. A topical formulation of HAT-01, HAT-01P1, and/or HAT-01P2
was randomly and blindly provided (without patient knowledge) and
followed through 2, 4, 8, and 12 weeks after treatment. Patients
were assessed both before and throughout the course of treatment
(each visit) for the following indices: SCORAD (SCORing Atopic
Dermatitis), Patient Benefit Index. Each patient also had up to 10
mls of blood drawn prior to (0) and at 4, and 12, weeks
post-therapy to distinguish laboratorial and cytokine changes over
time. Serum from 64 patients with AD on an approved randomized
single blind placebo-controlled clinical trial of HAT-01, placebo
and partial formulations of HAT-01 were obtained for all groups at
3 time points (0, 4, 12 weeks).
[0149] Therapeutic Effects of HAT-01 in Patients with Atopic
Dermatitis: Pilot Trial
[0150] To correlate our findings in human patients with AD, we
performed an exploratory 10-week, open-label study to evaluate the
utility of HAT-01 in atopic dermatitis. Significant resolution of
symptoms and signs of AD was observed through a Three Item Severity
score in 15 of 18 patients after 4 weeks of topical HAT-01
treatment, with no relapses at 10-weeks of follow up. We then
performed pilot clinical studies to evaluate the utility of HAT-01
in atopic dermatitis. Patients with severe asthma and/or those
treated with systemic or topical (greater than medium strength)
corticosteroids or immunosuppressant agents were excluded from the
study. An exploratory 10-week, open-label study was designed to
investigate the safety, efficacy and tolerability of a twice-daily
application of a topical formulation of HAT-01 in AD. A total of 18
patients fulfilling diagnostic criteria for AD were enrolled and
placed on a regimen of twice daily application of a topical
formulation of HAT-01 (300 .mu.l of 1:10). FIG. 2 portrays the
design outline of this pilot trial. The primary efficacy outcome
was defined as the change in the Three Item Severity score (TIS
score) of AD based on the evaluation of erythema, oedema/papulation
and excoriation in each representative lesion. Significant
resolution of symptoms and signs of AD was observed in 83% of
patients (15 of 18) after 4 weeks of HAT-01 treatment, with no
relapses at 8-week or 10-week follow up (FIG. 3). Patients with
severe disease activity pretreatment (TIS score>6) demonstrated
an average 54.6% reduction in disease activity at 4-weeks, and an
average of 77.1% reduction in disease activity by 10-weeks (FIG.
3). Of note, a significant reduction in edema and erythema was
observed within 2-weeks, which was followed by improvements in
oozing and excoriations within 4 weeks following treatment with
HAT-01. Significant improvement in xerosis (dryness) was also
immediately observed, while improvement in lichenification
(thickening) took up to 10 weeks for effective resolution.
[0151] AD: Therapeutic effects of HAT-01 in patients with atopic
dermatitis: Randomized placebo-controlled trial. To further
investigate the safety, efficacy and tolerability of a twice-daily
application of a topical formulation of HAT-01 in atopic dermatitis
(AD), a total of 64 patients fulfilling inclusion criteria for AD
were enrolled into a randomized placebo-controlled single (patient)
blind clinical trial with a regimen of twice daily application of a
topical formulation of HAT-01 (300 .mu.l of 1:10). The primary
efficacy outcome was defined as the change in the Severity Scoring
of Atopic Dermatitis (SCORAD) values. SCORAD values, ranging from 0
to 103, are classified as mild (<15), moderate (16-40) and
severe (>41), and are calculated as
(0.2.times.Area)+(3.5.times.Erythema+Edema+Crust+Excoriation+Lichenificat-
ion+Dryness)+(pruritis+sleep loss). As shown in FIG. 4, significant
resolution of symptoms and signs of AD was observed in 84% of
patients after 4 weeks of HAT-01 treatment, with sustained effects
and no relapses at 8-week or 12-weeks of follow up (FIG. 4).
Placebo (vehicle) treatment had no significant effect on SCORAD
values, and treatment with partial formulations HAT-01:P1 and
HAT-01:P2 had only minimal effects relative to treatment with whole
HAT-01 (FIG. 4). Significant reduction in edema and erythema was
observed within 4-weeks, which was followed by improvements in
oozing and excoriations within 8 weeks following treatment with
HAT-01. Significant improvement in xerosis was also observed at 4
weeks, while improvement in lichenification took up to 12 weeks for
effective resolution. Importantly, HAT-01 was well tolerated and no
treatment-related adverse events were observed throughout the
12-week pilot trial, indicating the safe and potent therapeutic
benefit of HAT-01 in a majority of the patients studied with
AD.
* * * * *