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.

Completed

• Conditions: Psoriasis, unspecified,

• Registration Number: CTRI/2014/01/004277
• Lead Sponsor: Dr JRKs Siddha Research and Pharmaceuticals Private Limited

Brief Summary

This is a prospective, randomised, double blind, placebo controlled clinical study on two proprietary herbal medicines to be used as Mono Therapy and Combination Therapy in adults with moderate to severe psoriasis.

The study is planned and conducted in three different sites with a Alternate Medical Expert, a Dermatologist and a Medical Pharmacologist as Investigators.

42 subjects enrolled are randomised in a 2: 1 ratio in to the two arms of the study - Combination Therapy (28 subjects) Arm and Mono Therapy (14 subjects) Arm.

**Composition of the Interventions:**

**777 oil  : Oil extracts of** Wrightia tinctoria ( Swetha kutaja ) : **50% W/V**  & Oleum Cocos nucifera (Narikela )     : **50% W/V**

**Psorolin Ointment  : Oil extracts of** Wrightia tinctoria ( Swetha kutaja) : 33% , Cynadon dactylan ( Dhoorva) : 33% and Petroleum jelly base  :  33%

**Combination Therapy Arm: Combination of Ointment and Oil Therapy - 28 subjects**

Psorolin ointment or Placebo ointment is applied twice a day- morning and evening for 12 weeks.

777 oil is applied once a day in the evening for 12 weeks.

The subjects in the combination therapy arm will receive either psorolin ointment or placebo in a 1: 1 ratio. All subjects in the combination therapy arm will receive 777 oil.

**Mono Therapy Arm: Psorolin Ointment Only - 14 subjects**

These subjects will receive only Psorolin ointment that is applied twice a day- morning and evening for 12 weeks.

**Objective assessments** such as PASI (Psoriasis Area and Severity Index) and PGA (Physician’s Global Assessment) and **Subjective Assessments** such as DLQI (Dermatology Life Quality Index), Subjective Self Assessment Questionnaire and Subject IP Feedback Questionnaire are assessed as **Baseline on Visit 1 (week 0) and again during Visit 2 (Week 4), Visit 3 (Week 8) and Visit 4 ( week 12) for improvement metrics.**

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-25
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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	1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | 2. Physician’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)
2.Physician’s Global Assessment (PGA): Score of 2 or less from from V1- V4	1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | 2. Physician’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)
3.Dermatology Life Quality Index (DLQI): Score 0-8 by V4. study.	1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | 2. Physician’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)
4.Subjective Self Assessment Questionnaire: Increase of 12 Scores from V1- V4	1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | 2. Physician’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)
5.Subject IP Feedback Questionnaire: Score ≥12 by V4	1. Psoriasis Area and Severity Index (PASI): At V1 (week0), V2 (4 weeks), V3 (8 weeks), V4 (12 weeks) | 2. Physician’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 Outcome Measures

Name	Time	Method
1.Psoriasis Area and Severity Index (PASI): PASI50 or 50% improvement from V1- V4	2.Physician’s Global Assessment (PGA): Score of 3 or 4 from V1- V4

Trial Locations

Locations (3)

A.N. Skin & Cosmetics Clinic,; 🇮🇳 Chennai, TAMIL NADU, India

Aushadham Ayurvedic Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Raam Poly Clinic; 🇮🇳 Chennai, TAMIL NADU, India

A.N. Skin & Cosmetics Clinic,

🇮🇳Chennai, TAMIL NADU, India

DrJayaraaman MD DD

Principal investigator

9444119274

jayaraamana@gmail.com