Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: Psorolin Oil: Oil extracts of Wrightia tinctoria 100mg , Indigofera tinctoria :50mg, Indigofera aspalathoides 25mg, Olium Cocos nucifera (Q.S)
Take adequate amount to apply a thin lay
Sponsors
Dr JRKs Siddha Research and Pharmaceuticals Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female Adults between the ages of 18 and 50 years (both ages inclusive) 2. Psoriasis Body Surface Area at baseline is >3% 3. Subject w ho understand and willing to sign informed consent document before start of any study specific assessment. 4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial. 5. Subject has not participated in a similar investigation in the past four weeks.
Exclusion criteria
Exclusion criteria: 1. Subjects with Psoriatic Arthritis. 2. Ongoing topical treatment or remedial measures for psoriasis inclusive of creams, lotions and oils 2 weeks before inclusion into the study. 3. Subjects currently receiving drugs like Lithium, B- blockers, Antimalarials and NSAIDs or using corticosteroids and anti-inflammatory medicines until 15 days before inclusion into the study. 4. Subjects are using DMARDS or are on Psoralen+UVA - Phototherapy 4 weeks prior to inclusion into the study. 5. Subject with history of cancer including skin cancer. 6. Subject with serious dermatological infection in past three months requiring systemic therapy. 7. Subjects with facial melasma, lesions and other types of skin damage that is not psoriasis. 8. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection. 9. History of opportunistic infections (e.g., systemic fungal infections, parasites) 10. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, severe cardiovascular, pulmonary, (especially COPD where steroid treatment is required), cerebral, hematologic, neurological or psychiatric disease or any other serious medical illness. 11. A known history or present condition of allergic response to any cosmetic products. 12. Females who are pregnant or lactating or planning to become pregnant during the study period. 13. Subjects who maybe allergic to any of the natural constituents of the Investigational Product. 14. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Psoriasis Area and Severity Index (PASI): PASI 75 or 75% improvement from Visit 1 to End of Study. 2. Physicianâ??s Global Assessment (PGA): Score of 2 or less from Visit 1 to End of Study. 3. Dermatology Life Quality Index (DLQI): Score 0-8 by Visit 3 (End of study). 4. Subjective Self Assessment Questionnaire: Increase of â?¥12 scores from Visit 1 to Visit 3. 5. Subject IP Feedback Questionnaire: Score â?¥ 12 by Visit 3. Timepoint: 1. Psoriasis Area and Severity Index (PASI): Visit 0, Visit 1 (Day 1), Visit 2(Day 15), Visit 3(Day 30). 2. Physicianâ??s Global Assessment (PGA): Visit 1 (Day 1), Visit 2(Day 15), and Visit 3 (Day 30). 3. Dermatology Life Quality Index (DLQI): Visit 1 (Day 1), Visit 2(Day 15), and Visit 3 (Day 30). 4. Subjective Self Assessment Questionnaire: Visit 1 (Day 1), Visit 2(Day 15), Visit 3 (Day 30). 5. Subject IP Feedback Questionnaire: Visit 2(Day 15), Visit 3 (Day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psoriasis Area and Severity Index (PASI): PASI 50 or 50% improvement from Visit 1 to end of study. 2. Physicianâ??s Global Assessment (PGA)): Score of 3 or 4 from Visit 1 to End of study. 3. Dermatology Life Quality Index (DLQI): Score 9-16 by end of study. 4. Subjective Self Assessment Questionnaire: Increase in score of 8-11 by end of study. 5. Subject IP Feedback Questionnaire: Score 8-11 by end of study. Timepoint: 1. Psoriasis Area and Severity Index (PASI): Visit 0, Visit 1 (Day 1), Visit 2(Day 15), Visit 3(Day 30). 2. Physicianâ??s Global Assessment (PGA): Visit 1 (Day 1), Visit 2(Day 15), and Visit 3 (Day 30). 3. Dermatology Life Quality Index (DLQI): Visit 1 (Day 1), Visit 2(Day 15), and Visit 3 (Day 30). 4. Subjective Self Assessment Questionnaire: Visit 1 (Day 1), Visit 2(Day 15), Visit 3 (Day 30). 5. Subject IP Feedback Questionnaire: Visit 2(Day 15), Visit 3 (Day 30). | — |
Countries
India
Contacts
Public ContactDr VTSriraam
Aurous HealthCare
Outcome results
None listed