Description: Title: Cannabis based skin care composition
Field of Invention:
The present invention relates to skin healing herbal composition. More particularly, the present invention relates to herbal composition for hydrating dry skin and improving skin conditions like psoriasis, eczema.

Background of Invention:
Skin is the largest organ of the body which provides the perfect barrier from physical, chemical, and biological external agents. Variations in the environmental stimuli and natural ability to deal with these factors causes undesired changes in skin which results in skin diseases and disorder. The most common skin disease and disorder include Eczema, Psoriasis, burn wounds, scaring of skin, discolouration, dry skin, skin allergies etc.,
Eczema is characterized by initial symptoms of blistering and dry cracked skin on the hands and feet. The disease develops progressively into continual scaling, peeling cracked skin. The skin becomes itchy, red, and inflamed. Similarly, Psoriasis is a skin condition that speed up life cycle of skin cells. It causes cells to build up rapidly on the surface of the skin. The extra skin cells form scales and red patches that are itchy and sometimes painful.
The most common treatment for such skin disorder includes phototherapy or light therapy, a treatment that uses ultraviolet light to reduce skin inflammation. The biggest drawback of light therapy is that it is very time consuming. Additionally, the light therapy may cause burning, headache and nausea, skin damage, and even skin cancer.
Another common treatment is prescription topical medication and/or over the counter (OTC) remedies, for instance, the use of Cortisone steroid creams. This type of treatment is easy to use, works fast, and costs less than many other treatments. However, the steroid cream treatment normally reduces the symptoms such as itchiness temporarily. As soon the treatment stops, the skin condition may come back and becomes even worse than before the treatment. Further, this type of treatment may cause addition and tolerance to the steroid chemicals, and side effects such as skin thinning and degrading, bruising, toxin build-up in the body, and hormone suppression, etc.
The present invention overcomes the drawbacks of the treatments in the state of art and is an effective alternative to chronic topical steroid use.

Object of the Invention:
The primary objective of the invention is to provide an herbal cream composition comprising extract of cannabis sativa.
Another object of the invention is to provide a skin care composition with unique combination of herbs, oils, and additives having synergistic effect in combination, for the treatment of skin disease and disorders like eczema, psoriasis, dry skin etc.

Summary of Invention:
The herbal skin care composition is a cream or a lotion that moisturizes the skin, improving skin conditions like eczema, psoriasis, and hydrates dry skin.
The present invention is an herbal skin care composition, wherein said composition comprises extracts and/or oils of Garcinia indica (Kokum), Calendula officinalis (Zergul), Cannabis sativa (Vijaya), Aloe barbadensis (Ghrita kumara), Glycyrrhiza glabra Linn. (Yashtimadhu), Butyrospermum parkii (Shea), Vetiveria zizanioides (Ushira), Artemisia vulgaris (Nagdamani). In addition, the herbal skin care composition contains emulsifiers, stabilizers, emollients and water. The skin care also contains a fragrance and a preservative.
The skin care composition is formulated as a cream or lotion having butter like consistency. When applied topically, the composition moisturizes the skin, relives inflammation and itching, and improve skin disorders like eczema and psoriasis.

Brief Description of Drawing:
Figure 1: process for producing Garcinia indica Butter.
Figure 2: process for producing Calendula officinalis Flower extract.
Figure 3: process for producing Cannabis sativa seed oil.
Figure 4: process for producing Cannabis sativa leaf extract.
Figure 5: process for producing Aloe barbadensis juice.
Figure 6: process for producing Glycyrrhiza glabra roots extract.
Figure 7: process for producing Butyrospermum parkii butter.
Figure 8: process for producing Vetiveria zizanioides roots extract.
Figure 9: process for producing Artemisia vulgaris oil.
Figure 10: Flow chart for preparation of the present invention.
Figure 11: The graphical representation of the EASI Score where X-axis is number of visits and Y-axis is the EASI Score.
Figure 12: the graphical representation of the SCORAD Score where X-axis is number of visits and Y-axis is the SCORAD Score.
Figure 13: The graphical representation of the VAS Score where X-axis is number of visits and Y-axis is the VAS Score.
Figure 14: The graphical representation of the SIGA Score where X-axis is number of visits and Y-axis is the SIGA Score.

Detailed Description of Invention:
The present invention is a skin care herbal composition formulated as a cream or lotion that hydrates dry skin and aids in healing skin disorders, skin allergies, eczema, psoriasis and skin redness.
Garcinia indica (Kokum) is used as kokum butter which has antioxidant properties. The Garcinia indica seeds [101] are cleaned and sun dried to remove excess moisture. Garcinia indica dry seeds [102] are then hulled to expose kernels and shells which then undergo process of winnowing to retains Garcinia indica kernels [103]. The Garcinia indica kernels [103] are heated and passed through oil expeller to obtain crude Garcinia indica oil [104]. crude Garcinia indica oil [104] is heated to remove impurities and obtain pure Garcinia indica oil [105]. After filtration, the pure Garcinia indica oil [105] is churned to obtain Garcinia indica butter [106].
Calendula officinalis (zergul) is rich in antioxidants, soothes irritated skin and promotes faster wound healing. Calendula officinalis flower [201] is dried at room temperature to obtain Calendula officinalis flower powder [202]. The Calendula officinalis flower powder [202] is then extracted in alcohol to obtain Calendula officinalis flower extract [203]. Alternatively, it can also be made from Calendula officinalis flower [201] by extracting Calendula officinalis fresh flower [201] directly in alcohol.
Cannabis sativa (Vijaya) has anti-inflammatory properties and helps in hydrating dry skin. The Cannabis sativa oil [302] is usually prepared by solvent extraction or by cold pressing. The present invention uses cold pressing method to obtain Cannabis sativa seed oil [302] from Cannabis sativa seed [301]. Cannabis sativa is also used as leaf extract in the present invention. Cannabis sativa leaf [401] is air dried and then extracted using alcohol by Soxhlet extraction process to obtain Cannabis sativa leaf extract [402].
Aloe barbadensis (Ghrita Kumara) has cooling properties, anti-inflammatory, rich in antioxidants and minerals that boosts the healing process. The present invention uses Aloe barbadensis juice in the composition. Aloe barbadensis leaves [501] are blended to obtain Aloe barbadensis juice [502].
Glycyrrhiza glabra (Yastimadhu) is antioxidant which protects skin against free radicals, it also shows anti-inflammatory properties, and helps in wound healing, skin whitening, skin depigmentation. Glycyrrhiza glabra roots [601] are milled and sieved to obtain Glycyrrhiza glabra root powder [602]. Glycyrrhiza glabra root powder [602] is extracted using aqueous solvent by ultrasonic extraction process to obtain Glycyrrhiza glabra root extract [603].
Butyrospermum parkii protects against skin dryness, soothes inflamed skin. Butyrospermum parkii nuts [701] are cracked to obtain Butyrospermum parkii kernels [702] which are sun dried. These Butyrospermum parkii kernels [702] are passed through oil expeller to obtain Butyrospermum parkii oil [703] which is then churned to obtain Butyrospermum parkii butter [704].
Vetiveria zizanioides (Ushira) is an aromatic plant having antioxidant activity. Vetiveria zizanioides roots [801] are extracted using supercritical CO2 extraction using ethanol as solvent to obtain Vetiveria zizanioides oil [802].
Artemisia vulgaris (Nagdamani) has antiseptic properties. Artemisia vulgaris leaves [901] are oven dried at 40?C. Artemisia vulgaris dried leaves [902] are extracted with water by hydro-distillation to obtain Artemisia vulgaris oil [903].
The skin care composition comprises of plant parts extract of Calendula officinalis extract [203], Aloe barbadensis juice [502], Glycyrrhiza glabra root extract [603], and Cannabis sativa leaf extract [402].
The skin care composition contains oils from medicinal plants such as Cannabis sativa seed oil [302], Vetiveria zizanioides oil [802], and Artemisia vulgaris oil [902].
The skin care composition contains moisturizers including Garcinia indica butter [106] and Butyrospermum parkii butter [704].
The skin care composition includes water, which is preferably distilled water [111] or otherwise purified water.
The skin care composition contains following excipients: a emulsifier [112], such as emulsifying wax (vegetable-based emulsifying waxes typically include at least cetearyl alcohol and polysorbate 60) and Stearic acid, a humectant [113] such as glycerine, a film former [114] such as white bees wax, a thickening agent [115] such as Sodium acryloyl dimethyl taurate copolymer, Isohexadecane, Polysorbate 80, a preservative [116] such as 2-phenoxyethanol, 1,3-Bis(hydroxymethyl)-5-5-dimethylimidazolidine-2,4-dione (DMDM Hydantoin), a masking agent [117] such as perfume, a chelating agent [118] such as Disodium EDTA.
In one embodiment as an example of skin care composition according to the present invention is made from the ingredients listed in Table 1 below.
Table 1
INGREDIENTS Part Used Form F1
% (w/w) F2
%
(w/w) F3
%
(w/w)
ACTIVE INGREDIENTS
Garcinia indica (Kokum) Seed Butter 6.0 5.0 7.0
Calendula officinalis (Zergul) Flower Extract 5.0 4.0 6.0
Cannabis sativa (Vijaya) Seed Oil 5.0 4.0 6.0
Aloe barbadensis
(Ghirta Kumara) Leaf Extract 5.0 4.0 6.0
Glycyrrhiza glabra (Yashtimadhu) Root Extract 3.0 2.0 4.0
Butyrospermum parkii (Shea) Seed Butter 3.0 2.0 4.0
Cannabis sativa (Vijaya) Leaf Extract 2.0 1.0 3.0
Vetiveria zizanioides (Ushira) Root Oil 0.1 0.09 0.11
Artemisia vulgaris (Nagdamani) Seed Oil 0.1 0.09 0.11
EXCIPIENTS
Distilled Water 58.30 65.32 51.28
Emulsifying wax 3.0 3.0 3.0
Glycerine 2.0 2.0 2.0
White Beeswax 2.0 2.0 2.0
Cetyl alcohol 2.0 2.0 2.0
Acrylamide/ Sodium Acryloyl dimethyl Taurate Copolymer & Isohexadecane & Polysorbate 80 2.0 2.0 2.0
2-Phenoxyethanol 0.6 0.6 0.6
Perfume 0.4 0.4 0.4
1,3-Bis (hydroxymethyl) -5-5- dimethylimidazolidine-2,4-dione (DMDM Hydantoin) 0.36 0.36 0.36
Disodium EDTA 0.1 0.1 0.1

The ingredients are mixed together in four phases called as Phase A, Phase B, Phase C and Phase D. The ingredients in Table 1 are all measured.
In Phase A Distilled Water [111], Disodium EDTA, and Glycerine are combined in main vessel [1001] and heated up to 70?C - 75?C.
In Phase B Garcinia indica butter [106], Cannabis sativa seed oil [203], Butyrospermum parkii butter [704], Vetiveria zizanioides oil [802], Artemisia vulgaris oil [903] are heated to 70?C - 75?C in a side vessel [1002]. The mixture of Phase B is slowly poured in main vessel containing mixture of Phase A. Phase A and Phase B mixture is mixed with help of homogenizer [1003] to uniformly mix oil phase and aqueous phase.
Then in Phase C, Simugel 600 is added to main vessel [1001] and mixed uniformly. This entire mixture is cooled to 40?C. As the mixture cools, it thickens and colour changes to white.
In Phase D 2-Phenoxyethanol, Perfume, 1,3-Bis (hydroxymethyl) -5-5- dimethylimidazolidine-2,4-dione (DMDM Hydantoin), Calendula officinalis extract [203], Aloe barbadensis juice [502], Glycyrrhiza glabra root extract [603], Cannabis sativa leaf extract [402] are mixed in main vessel [1001] after the entire mixture is cooled to 40?C.
This final product is made into a composition intended for topical use in the form of cream however it can also be formed in the form of gel, lotion, or the like.
Clinical trial is carried out at National Institute of Ayurveda, Jaipur Rajasthan.
The study is designed to evaluate the efficacy of Modified Vijaya oil (skin health cream) in patients suffering from skin disorders or diseases in terms of changes in EASI Score, SCORAD, VAS, and SIGA before and after the intervention, i.e., between Day 0 and Days 30. As a part of the study, 40 patients were enrolled who are clinically diagnosed with eczema and based on inclusion-exclusion criteria after obtaining informed consent. F1 cream was used for the study. The trial period is for 30 days (5 visits – 0, 7, 15, 21, 30 days) and the F1 cream was dispensed in the visit 1 and further dispensing was done according to the requirement of the patient, i.e., based on the affected area on the body. The cream was given for topical application at room temperature twice a day in the morning and evening and the efficacy was assessed based on the above said scores on every subsequent visit, until the completion of the trial.
On every follow up visit, following parameters are assessed:
1. Eczema Area Severity Index (EASI Score) was evaluated to assess any change in eczematous lesion (redness, thickness, scratching) on a specific region of the body.
2. Scoring Atopic Dermatitis was evaluated to assess the intensity, extent of spread and also subjective symptoms like insomnia and pruritus (VAS). SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis)
3. Assessment of change in SIGA. The SIGA consist of a 6-point severity scale from clear to very severe disease. The SIGA assessed the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting of the overall severity assessment.
4. Assessment of Clinical photographic changes in eczematous lesion. Photographs are taken on every visit and compared with baseline on graded scale.

The following case studies illustrate use of the composition:
Case Study 1:
The composition was used to treat eczema on a forty-nine-year-old female. The eczema was on the neck and legs and a large portion on shoulder. The eczema had been recurring for a period of 2 years and caused itching. Upon topical application of the cream to the affected area two times a day, relieved itching within first two days. Within one week, the itching stopped completely. Within three weeks the appearance of the skin has improved.

Case Study 2:
The composition was used to treat white patch in a fifty-nine-year-old female. The subject’s hand was particularly affected, and sleeping was adversely affected by nocturnal itching. The skin care composition was applied twice a day. Within few days, the symptoms were reduced but later the symptoms aggravated.

Case Study 3:
An adult male had very dry skin that showed some cracks in the skin. The skin care composition was applied twice a day. Within two weeks, the skin was noticeably softer, rejuvenated, hydrated and the dry crackly skin had smoothed out.

Case Study 4:
A twenty-five-year-old male showed oozing and crusting on foot and some part of legs. The skin care composition was applied twice a day. Within one week the oozing stopped and by the end of the study the crusting on foot was reduced.

Case Study 5:
The subject was twenty-four-year-old male having white patchy skin and itching on arms. The skin care composition was used twice a day and within two weeks the itching stopped completely. At the end of four weeks the white patches were reduced.

Case Study 6:
The skin care composition was used to treat eczema on twenty-one-year-old female. The subject showed small blister the turned into skin cracks on palms and sole of the feet. The composition was used for a month twice a day. Withing ten days the cracks were healed. The skin started to smooth out and blisters disappeared.

Case Study 7:
A thirty-seven-year-old female suffered from itchy skin. The composition was used twice a day. At the end of the study the itching stopped completely.

Case Study 8:
The subject, forty-three-year-old male had dry flaky patches on knees. The skin care composition was used twice a day. Within three weeks the dry flaky skin patches were smoothed out.

Case Study 9:
The skin care composition was used to treat psoriasis in forty-two-year-old male. The subject showed red, swollen, thick skin. The skin care composition was used two times a day. The redness of the skin was reduced within first week of the use of composition. The thickness of the skin was reduced by the end of four weeks.

Case Study 10:
A forty-six-year-old female showed dry, scaly skin with red cracks on lower legs. The skin care composition was used two times a day for a month. The cracks were healed within two weeks and skin was smoothed by four weeks.

Case Study 11:
The skin care composition was used to treat psoriasis in twenty-two-year-old male. The subject showed patches of thick red skin with silvery white scales on neck and elbow. The skin care composition was used two times a day. The subject showed improved skin within three weeks. The white scales reduced within two weeks.
Case Study 12:
The skin care composition was used to treat eczema in fifty-nine-year-old female. The subject has thick, scaly patches on the nose and around eyes. The subject used the composition twice a day for a month. Within fifteen days the scaly patches on nose reduced and within twenty days the skin appearance improved.

Case Study 13:
The skin care composition is used to treat fifty-five-year-old female. The subject showed dry skin lesions on lower back. The plaques were itchy. The skin care composition was used twice a day. The itchiness stopped within a week of use of the composition and within fifteen days the skin was rejuvenated.

Case Study 14:
A twenty-six-year-old female showed scaly, silvery patches on her knees. The skin care composition was used for month twice a day. The patches were smoothed out within three weeks.

Case Study 15:
The subject is thirty-year-old female having dry skin and acne. The dry skin is in patches around neck and upper back. The skin care composition was used twice a day. The skin was noticeably hydrated and softer within two weeks.

Case Study 16:
The skin care composition is used to treat eczema in fifty-year-old female. The subject showed skin hives and lesions on feet. The subject applied the skin care composition twice a day. Within two days the skin hives were smoothed out. Within three weeks the skin lesions were reduced.

Case Study 17:
The skin care composition is used to treat psoriasis in fifty-nine-year-old female. The subject showed crackly skin with itching and redness. The skin care composition was applied twice a day. Within two weeks the itching was stopped. Within three weeks the skin was smoothed out.

Case Study 18:
The subject is sixty-one-year-old female having skin lesions on arms. The skin lesions are too dry which is causing itching. The subject is unable to sleep due to nocturnal itching. The skin care composition was applied by the subject twice a day. In one week, the itching stopped, and the subject was able to sleep. Within two weeks the skin lesions were reduced. There was noticeable improvement in appearance of skin.

Case Study 19:
The skin care composition is used to treat psoriasis in a thirty-five-year-old male. The subject has blisters on legs. The blisters are oozing. The skin care composition is applied twice a day. At the end of the study the results showed decrease in the blister and hydration of skin.

Case Study 20:
The skin care composition is used to treat psoriasis in fifty-year-old male. The subject has silver scales on the legs. The scales cause itching and thick skin. The skin care composition is applied twice a day. Within two weeks the itching reduced and at the end of the study the skin was smoothed out and scales were reduced.

Case Study 21:
The subject is sixty-seven-year-old male having white silvery patches on entire back. The patches are crackly. The skin care composition is applied twice a day. It was observed that within three weeks the cracked skin was healed, and the patches were smoothed out.

Case Study 22:
The subject is thirty-nine-year-old male, showing red patchy skin with skin hives and itching on arms and legs. The skin care composition is used twice a day. At the end of the study, it was observed that the red patches were reduced, and skin hives were smoothed out.

Case Study 23:
The skin care composition is used to treat eczema in forty-six-year-old male. The subject shows thick, leathery patchy skin on abdomen. The skin care composition was used twice a day for month. It was observed that, within two weeks the patches were reduces. The skin appearance improved at the end of the study.

Case Study 24:
The skin care composition is used to treat eczema on thirty-two-year-old male. The subject shoed skin swelling and itching on arms and neck. The skin care composition was used twice a day. At the end of the study, it was observed that, the swelling is reduced. The itching stopped within 5 days of the use of the skin care composition.

Case Study 25:
The skin care composition is used to treat eczema on sixty-six-year-old female. The subject shows dry flaky skin on knees and elbows. The skin care composition is used twice a day. Within three weeks the skin was smoothed out.

Case Study 26:
The skin care composition was used to treat eczema on sixty-six-year-old female. The subject shows blister that ooze on the arms. The skin care composition was used twice a day. At the end of the study the skin blisters were reduced.

Case Study 27:
The subject is eighteen-year-old female having redness and swelling of skin around neck. The skin is itchy. The subject used the skin care composition twice a day. At the end of the study, it was observed that the skin was smoothed out and hydrated. The itching was stopped within ten days of the use of composition.

Case Study 28:
The skin care composition is used to treat psoriasis in twenty-one-year-old female. The subject shows itchy scales on the legs. The skin care composition was applied to affected area twice a day. At the end of the study, it was observed that the scales are reduced, and skin appearance is improved.

Case Study 29:
The subject is forty-five-year-old female having red inflamed patches on the back. The subject applied the skin care composition on the affected area twice a day for a month. At the end of the study, it was observed that inflammation is reduced.

Case Study 30:
The subject is thirty-four-year-old female. The skin care composition is used to treat crusty skin on foot of the subject. The subject applied the skin care composition twice a day on the affected area. Within three weeks the crusty skin was smoothed out.

Case Study 31:
The skin care composition is used to treat psoriasis in forty-year-old male. The skin care composition was applied to affected areas twice a day. At the end of the study, it was observed that the swelling is reduced, and scales are reduced.

Case Study 32:
The subject is sixteen-year-old female having dry skin and acne. The subject used the skin care composition twice a day. At the end of the study, it was observed that the skin was softer, rejuvenated and hydrated.

Case Study 33:
The subject is a fifty-two-year-old male having psoriasis. The subject showed skin lesions on feet and palms. The skin care composition was used twice a day. At the end of the study, it was observed that the skin lesions on palm and feet was reduced.

Case Study 34:
An adult fifty-seven-year-old male showed thick scaly skin patches on neck. The subject used the composition twice a day and within two weeks the scales reduced, and the skin appearance was improved.

Case Study 35:
The subject, forty-seven-year-old female showed dry skin and acne on face. The subject used the composition twice a day. Within one week of use the subject had hydrated skin and smooth skin.

Case Study 36:
A sixteen-year-old male showed dry flaky patches of skin oozing a clear fluid on elbows. The composition was applied twice a day. Within 3 weeks the oozing stopped, and skin was hydrated.

Case Study 37:
The composition was used to treat psoriasis on fifty-nine-year-old male. The subject was suffering from nocturnal itching and red patchy skin.

Case Study 38:
A thirty-seven-year female had chronic psoriasis on leg. The composition was used twice a day. Initially there was relief of symptoms but by third week the subject developed dryness which further led to increase in itching. The application of the composition was incorrect.

Case Study 39:
The composition was used to treat eczema thirty-four-year-old female. The subject developed white crusty rash on face. The application of the composition twice a day decreased the rash on face at the end of the trial.

Case Study 40:
The composition was used to treat psoriasis twenty-four-year-old male. The subject suffered from skin lesions on lower back. The composition was used twice a day. The skin lesions reduced within three weeks.

The data of all 37 subjects who successfully completed the study was considered for the statistical analysis.
1. EASI
From the total score obtained, the severity is graded as follows:
0=clear
0.1-1=almost clear
1.1-7=mild
7.1-21=moderate
21.1-50=severe
50.1-72=very severe

Table 2
Average of EASI Visit 1 Average of EASI Visit 5 Difference Percentage of Relief p-value Significance
6.58
2.83 3.75 57% <0.0001 Highly significant

Figure 11 show the graphical representation of the EASI Score where X-axis is number of visits and Y-axis is the EASI Score.

Observation: A Significant decrease was observed in mean values of EASI score when compared to baseline which implies that the cream was efficient in reducing redness, inflammation, itching, and thickness of the skin.

2. SCORAD
The severity grading is:
<25 – Mild
25-50 – Moderate
>50 – Severe

Table 3
Average of SCORAD Visit 1 Average of SCORAD Visit 5 Difference Percentage of Relief p-value Significance
38.83
13 25.82 66% <0.0001 Highly significant

Figure 12 show the graphical representation of the SCORAD Score where X-axis is number of visits and Y-axis is the SCORAD Score.

Observation: A significant decrease was observed in mean values of SCORAD when compared to baseline which implies that the cream was efficient in reducing especially the dryness and lichenification if present (in chronicity), along with other symptoms.

3. Visual Analogue Scale (VAS)
It is assessed based on a scale ranging from 0 to 10. VAS for itch intensity: 0 being no itch and 10 being worst itch. VAS for sleep disturbance (nocturnal itch): 0 being no sleep loss and 10 beings cannot sleep at all.

Table 4
Average of VAS Visit 1 Average of VAS Visit 5 Difference Percentage of Relief p-value Significance
11.92
4 7.92 66% <0.0001 Highly significant

Figure 13 show the graphical representation of the VAS Score where X-axis is number of visits and Y-axis is the VAS Score.

Observation: A significant decrease was observed in mean values of VAS when compared to baseline which implies that cream was efficient in diminishing itching to a very good extent.
It was also notice that (during the baseline visit) among 37 subjects, only 13 subjects had sleep disturbance due to itching whereas 22 subjects could take a sound sleep and 2 subjects felt more sleepiness than usual.

4. SIGA
The severity scale ranges from:
0 = clear
1 = almost clear
2 = mild disease
3 = moderate disease
4 = severe disease
5 = very severe disease

Table 5
Average of SIGA Visit 1 Average of SIGA Visit 5 Difference Percentage of Relief p-value Significance
3.27
1.62 1.65 50% <0.0001 Highly significant

Figure 14 show the graphical representation of the SIGA Score where X-axis is number of visits and Y-axis is the SIGA Score

Observation: A significant decrease was observed in mean values of SIGA when compared to baseline which implies that the cream was efficient in relieving itching, inflammation, oozing etc., thereby making the skin clear.

Conclusion:
The study was conducted to evaluate the efficacy of modified vijaya oil (skin health cream) in patients suffering from vicarcika(eczema). Out of the 37 patients who have completed the trial, except in 2, there was significant decline in itching, inflammation, oozing, lichenification etc after topical application of the cream for 30 days continuously. In patients with recent-onset and who had very less surface area affected, the skin became almost clear by third and fourth visit. Thus, the cream was efficacious in relief of symptoms like Redness, Oozing, Scratching, Inflammation, Lichenification.

Sameer Walimbe
[IN/PA 1277]
, Claims:
We Claim:
1. A herbal composition comprising of Garcinia indica butter [106], Calendula officinalis extract [203], Cannabis sativa seed oil [302], Cannabis sativa leaf extract [402] Aloe barbadensis juice [502], Glycyrrhiza glabra root extract [603], Butyrospermum parkii butter [704], Vetiveria zizanioides oil [802], Artemisia vulgaris oil [903] characterised in that Garcinia indica butter [106] is in range of 5.0 – 7.0% w/w, Calendula officinalis extract [203] is in range of 4.0 – 6.0% w/w, Cannabis sativa seed oil [302] is in range of 4.0 – 6.0% w/w, Cannabis sativa leaf extract [402] is in range of 1.0 – 3.0% w/w, Aloe barbadensis juice [502] is in range of 4.0 – 6.0% w/w, Glycyrrhiza glabra root extract [603] is in range of 2.0 – 4.0% w/w, Butyrospermum parkii butter [704] is in range of 2.0 – 4.0% w/w, Vetiveria zizanioides oil [802] is in range of 0.09 – 0.11% w/w, Artemisia vulgaris oil [903] is in range of 0.09 – 0.11% w/w and distilled water [111] in range of 50 – 65% w/w.

2. The herbal composition as claimed in claim 1, wherein the excipients are selected from the group consisting of an emulsifier [112], a humectant [113], a film former [114], a thickening agent [115], a preservative [116], a masking agent [117], a chelating agent [118].

3. The herbal composition as claimed in claim 1, wherein the said composition is formulated in a topical application form comprising a cream, a liquid, a microemulsion, a nanocream, a nanoemulgel or a lotion.

Sameer Walimbe
[IN/PA 1277]