| CTRI Number |
CTRI/2014/01/004277 [Registered on: 03/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
A Prospective, Double Blind, Randomised, Two Arm, Placebo Controlled 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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/DER/023/13 Version 01 dated 26-Sep-13 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Raam Poly Clinic |
| Address |
11/1C, Vanniar Street,
Choolaimedu,
Chennai
TAMIL NADU
600094
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
raampolyclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Raam Poly Clinic |
| Address |
11/1C, Vanniar Street,
Choolaimedu,
TAMIL NADU
600094
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
raampolyclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Raam Poly Clinic |
| Address |
11/1C, Vanniar Street,
Choolaimedu,
TAMIL NADU
600094
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
raampolyclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr JRKs Siddha Research and Pharmaceuticals Private Limited |
|
|
Primary Sponsor
|
| Name |
Dr JRKs Siddha Research and Pharmaceuticals Private Limited |
| Address |
19, Perumal Koil Street,Kunrathur, Chennai - 600 069 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
G1-G2, RR Villa, No.180/109, Rangarajapuram Main Road, Kodambakkam, Chennai - 600 024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJayaraaman MD DD |
A.N. Skin & Cosmetics Clinic, |
25 TNHB Shopping Complex, 4 Luz Church Road(Navasakthi Vinayakar Temple), Mylapore,
Chennai
TAMIL NADU |
9444119274
jayaraamana@gmail.com |
| DrVeeracholan BAMS |
Aushadham Ayurvedic Clinic |
No 35, Laxmathi towers, Padmanaba Street (Near Sarathy Street), T.Nagar, Chennai
Chennai
TAMIL NADU |
9444443344
cholanayur@gmail.com |
| Dr VT Sriraam MBBS MD Pharmacology |
Raam Poly Clinic |
11/1c, Vanniar Street,
Choolaimedu
Chennai
TAMIL NADU |
9840909155
raampolyclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee - Dr Jayaraaman |
Approved |
| Universal Ethics Committee - Dr Veeracholan |
Approved |
| Universal Ethics Committee - Dr VT Sriraam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
777 oil |
A proprietary Siddha formulation containing herbal extracts.
A thin film of the oil is to be applied over the site of Psoriasis once a day - in the evening for 12 weeks. |
| Comparator Agent |
Placebo |
Placebo in ointment formulation.
A thin film of the ointment is to be applied over the site of Psoriasis twice a day - morning and evening for 12 weeks. |
| Intervention |
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 for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Psoriasis Area and Severity Index (PASI): PASI 75 or 75% improvement from V1- V4
2. Physician’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 ≥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
|
| Outcome |
TimePoints |
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
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. |
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) |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |