A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Two Proprietary Herbal Medicines as Mono Therapy and as Combination Therapy in Adult Subjects with Moderate to Severe Psoriasis.

Not Applicable

Completed

Conditions: Health Condition 1: L409- Psoriasis, unspecified

Registration Number: CTRI/2014/01/004277

Lead Sponsor: Dr JRKs Siddha Research and Pharmaceuticals Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Psoriasis Area and Severity Index (PASI): PASI 75 or 75% improvement from V1- V4 <br/ ><br>2.Physicianâ??s Global Assessment (PGA): Score of 2 or less from from V1- V4 <br/ ><br>3.Dermatology Life Quality Index (DLQI): Score 0-8 by V4. study. <br/ ><br>4.Subjective Self Assessment Questionnaire: Increase of 12 Scores from V1- V4 <br/ ><br>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) <br/ ><br>2. Physicianâ??s Global Assessment (PGA): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>3. Dermatology Life Quality Index (DLQI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>4. Subjective Self Assessment Questionnaire: At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>5. Subject IP Feedback Questionnaire: At V2 (4 weeks), V3 (8 weeks), V4 (12 weeks)

Secondary Outcome Measures

Name	Time	Method
1.Psoriasis Area and Severity Index (PASI): PASI50 or 50% improvement from V1- V4 <br/ ><br>2.Physicianâ??s Global Assessment (PGA): Score of 3 or 4 from V1- V4 <br/ ><br>3.Dermatology Life Quality Index (DLQI): Score 9-16 by V4. <br/ ><br>4.Subjective Self Assessment Questionnaire: Increase of 12 Scores from V1- V4 <br/ ><br>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) <br/ ><br>2.Physicianâ??s Global Assessment (PGA): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>3.Dermatology Life Quality Index (DLQI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>4.Subjective Self Assessment Questionnaire: At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) <br/ ><br>5.Subject IP Feedback Questionnaire: At V2 (4 weeks), V3 (8 weeks), V4 (12 weeks)