Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: Psorolin Ointment: A proprietary Siddha formulation containing herbal extracts.
A thin film of the ointment is to be applied over the site of Psoriasis twice a day - morning and evening
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. 2. Psoriasis Body Surface Area at baseline is between >=3% 3. Subject who 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 V1- V4 2. Physicianâ??s Global Assessment (PGA): Score of 2 or less from from V1- V4 3. Dermatology Life Quality Index (DLQI): Score 0-8 by V4. study. 4. Subjective Self Assessment Questionnaire: Increase of 12 Scores from V1- V4 5. Subject IP Feedback Questionnaire: Score â?¥12 by V4Timepoint: 1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 2. Physicianâ??s Global Assessment (PGA): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 3. Dermatology Life Quality Index (DLQI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 4. Subjective Self Assessment Questionnaire: At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 5. Subject IP Feedback Questionnaire: At V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psoriasis Area and Severity Index (PASI): PASI50 or 50% improvement from V1- V4 2. Physicianâ??s Global Assessment (PGA): Score of 3 or 4 from V1- V4 3. Dermatology Life Quality Index (DLQI): Score 9-16 by V4. 4. Subjective Self Assessment Questionnaire: Increase of 12 Scores from V1- V4 5. Subject IP Feedback Questionnaire: Score 8-11 by V4.Timepoint: 1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 2. Physicianâ??s Global Assessment (PGA): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 3. Dermatology Life Quality Index (DLQI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 4. Subjective Self Assessment Questionnaire: At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) 5. Subject IP Feedback Questionnaire: At V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Poly Clinic
Outcome results
None listed