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1 Clinical Trial Details (PDF Generation Date :- Fri, 26 Oct :38:49 GMT) CTRI Number Last Modified On 12/12/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2013/12/ [Registered on: 13/12/2013] - Trial Registered Retrospectively No Interventional Drug Unani Randomized, Parallel Group, Active Controlled Trial A clinical trial to compare the effects of coded Unani research drugs UNIM 001+UNIM003 with Psoralen in the treatment of vitiligo A multicentric single blind, randomized, parallel group, comparative study to compare the efficacy and safety of Coded Unani formulations UNIM 001+UNIM003 with Psoralen in the treatment of Bars (vitiligo ) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details of Principal Investigator New Delhi Details Contact Person (Scientific Query) page 1 / 5

2 Details Contact Person (Public Query) Details Contact Person (Public Query) Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Source of Monetary or Material Support > Infrastructural support : 1. Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine(RRIUM), Aligarh 3. Regional Research Institute of Unani Medicine (RRIUM), Srinagar 4. Regional Research Institute of Unani Medicine (RRIUM), New Delhi Monetary Support : New Delhi Type of Sponsor List of Countries of Principal Investigator DR M A WAHEED Primary Sponsor Details Central Council for Research in Unani Medicine CCRUM New Delhi Delhi-. Research institution of Site Site Phone/Fax/ Central Research Institute of Unani Medicine (CRIUM) DR ARJUMAND SHAH REGIONAL DR NAHEED KHATOON REGIONAL AG Colony road, Erragadda, Hyderabad Hyderabad ANDHRA PRADESH Naseem Bagh, Campus, Unvirsity of Kashmir, Srinagar Srinagar JAMMU & KASHMIR D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25 South mawaheeddst@gmail.c om arjusaju@hotmail.com dr.nahidparveen@yaho o.com page 2 / 5

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent DR PARVEZ KHAN REGIONAL Post Box 70, Near Head Post Office, ALIGARH Aligarh UTTAR PRADESH parvez@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? CRIUM HYDERABAD ETHICS COMMITTE, HYDERABAD, DR M A WAHEED, PRINCIPAL Approved 02/02/2013 No RRIUM ALIGARH ALIGARH, DR PARVEZ KHAN, PRINCIPAL Approved 28/03/2013 No RRIUM NEW NEW, DR NAHEED KHATOON, PRINCIPAL RRIUM SRINAGAR SRINAGAR, DR ARJUMAND SHAH, PRINCIPAL Status Not Applicable Health Type Patients Approved 06/02/2013 No Approved 19/11/2013 No Date No Date Specified Condition VITILIGO Type Details Comparator Agent psoralen Age Dose (mg) of psoralen mg mg mg Age Frequency tablets Single dose tablets Single dose tablets Single dose Duration of treatment is 8 months followed by 3 months post-treatment follow-up. Intervention UNIM-001 AND UNIM-003 UNIM-001 given orally according to per kg body body weight as mentioned in the protocol and UNIM003 given for topical application Duration of treatment is 8 months followed by 3 months post-treatment follow-up. Age Dose(mg)ofUNIM001&frequen mg 1 b.i.d page 3 / 5

4 Inclusion Criteria Age From Age To Gender Details 8.00 Year(s) Year(s) Both Inclusion Criteria 2400mg 1 t.i.d mg 2 b.i.d 1. Patients with clinically diagnosed dermatomal and non-dermatomal vitiligo 2. Subjects with 8-50 years of age. 3. Either gender 4. With any duration of disease, site, extension and distribution of lesions 5. Willingness to give written informed consent form. Exclusion Criteria Details Exclusion Criteria 1. Subjects with active vitiligo treatment with other drugs/systems 2. Non-cooperative subjects 3. H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period 4. Any clinically significant abnormality identified on physical examination or laboratory tests 5. Subjects having any systemic disease and other skin diseases. 6. Subjects with known allergies 7. Impaired Cardiac, Hepatic and Renal function 8. History of malignancy 9. Concomitant use of any other antioxidants 10. History of hypersensitivity to any of the investigational drugs/herbal medicine. 11. Receiving any other investigational product within 4 weeks 12. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being. 13. Uncontrolled infection 14. Pregnant and lactating women. Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Sequentially numbered, sealed, opaque envelopes Participant Blinded Primary Outcome Outcome Timepoints 1. To study and ensure the cosmetically acceptable re- pigmentation with 40% to 50% increase in VASI Score 2 To determine the time of initial re-pigmentation and subsequently the rate of re-pigmentation. 8 MONTHS Secondary Outcome Outcome Timepoints 1 To evaluate the overall safety, toxicity, acceptability of Unani drugs. 2 To study the Post- treatment retention of re-pigmentation at least for 3 months. 3. To evaluate the % of study participants responding to the Unani treatment and psoralen. 8 MONTHS Target Sample Size Total Sample Size=532 Sample Size from =532 page 4 / 5

5 Powered by TCPDF ( PDF of Trial Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 29/03/2013 No Date Specified Years=3 Months=0 Days=0 Not Applicable Open to Recruitment This study is designed as a multicentric single blind, randomized, parallel group, comparative study to compare the efficacy and safety of Coded Unani formulations UNIM 001+UNIM003 with Psoralen in the treatment of Bars (vitiligo). Self-reporting Vitiligo patients at Central Research Institute of Unani Medicine, Hyderabad/ and other allotted centres under CCRUM, will be assessed which will form the source of subjects for the study. Approximately in and around 532 clinically diagnosed Vitiligo patients with various ages, chronicities and of either gender will be enrolled in the study subject to fulfillment of inclusion criteria. After screening, participants will be divided into 2 arms. First arm will receive the study drug UNIM001+UNIM003 while the second arm will receive psoralen as treatment. The total duration of treatment will be 8 weeks All the parameters will be recorded at baseline, clinical follow up will be done once in a month for their evaluation as rate & % of re-pigmentation including the safety and efficacy parameters like LFT, RFT, ECG-QT interval. Follow up evaluation will be at least for 3 months to assess the retention of re-pigmentation. Response will be evaluated as follicular and peri-lesional re-pigmentation over the de-pigmented areas. Rate of % of re-pigmentation will be assessed. QOL index will be recorded initially and at the end of the study. Post-treatment follow-up will be done for 3 months in order to see the rate of re-pigmentation retained by the participants Age related dosing of psoralen 8-12 years: 10 mg; years: 15 mg; 19 years & above 20 mg. Age (in yrs) Weight (Kgs) Dose(mg)** of psoralen Frequency ±5% 20 (2 tablets) > ±5% 30 (3 tablets) > ±5% 40 (4 tablets) Ingredients of UNIM Babchi, 2. Zanjabeel, Ingredients of UNIM-003, 1. Babchi, 2. Gulnar page 5 / 5