| CTRI Number |
CTRI/2013/12/004215 [Registered on: 13/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of coded Unani research drugs UNIM 001+UNIM003 with Psoralen in the treatment of vitiligo |
|
Scientific Title of Study
|
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 ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
New Delhi
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
|
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 : Central Council for Research in Unani Medicine (CCRUM), New Delhi
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058.
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR M A WAHEED |
Central Research Institute of Unani Medicine (CRIUM) |
AG Colony road, Erragadda, Hyderabad- 500038
Hyderabad
ANDHRA PRADESH |
040-23810246
040-23811495
mawaheeddst@gmail.com |
| DR ARJUMAND SHAH |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
Naseem Bagh, Campus, Unvirsity of Kashmir, Srinagar- 190006
Srinagar
JAMMU & KASHMIR |
01942421604
01942421604
arjusaju@hotmail.com |
| DR NAHEED KHATOON |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
South
DELHI |
01126952759
01126952759
dr.nahidparveen@yahoo.com |
| DR PARVEZ KHAN |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
Post Box 70, Near Head Post Office, ALIGARH – 202 001
Aligarh
UTTAR PRADESH |
05712704781
05712701399
parvez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CRIUM HYDERABAD INSTITUTIONAL ETHICS COMMITTE, HYDERABAD, DR M A WAHEED, PRINCIPAL INVESTIGATOR |
Approved |
| RRIUM ALIGARH INSTITUTIONAL ETHICS COMMITTEE, ALIGARH, DR PARVEZ KHAN, PRINCIPAL INVESTIGATOR |
Approved |
| RRIUM NEW DELHI INSTITUTIONAL ETHICS COMMITTEE, NEW DELHI, DR NAHEED KHATOON, PRINCIPAL INVESTIGATOR |
Approved |
| RRIUM SRINAGAR INSTITUTIONAL ETHICS COMMITTEE, SRINAGAR, DR ARJUMAND SHAH, PRINCIPAL INVESTIGATOR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
VITILIGO, (1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
psoralen |
Age Dose (mg) of psoralen
12-18 20 mg
18-30 30 mg
30- 50 40 mg
Age Frequency
12-18 2tablets Single dose
18-30 3tablets Single dose
30-50 4tablets 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
12-18 1600mg 1 b.i.d.
18-30 2400mg 1 t.i.d
30-50 3200mg 2 b.i.d
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
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 India="532"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/03/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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; 13-18 years: 15 mg; 19 years & above 20 mg.
Age (in yrs) | Weight (Kgs) | Dose(mg)** of psoralen | Frequency | 12-18 | 30-50 ±5% | 20 | (2 tablets)Single dose | >18-30 | 50-60±5% | 30 | (3 tablets)Single dose | >30-50 | 60-70 ±5% | 40 | (4 tablets)Single dose |
Ingredients of UNIM-001 - 1. Babchi, 2. Zanjabeel,
Ingredients of UNIM-003 , 1. Babchi , 2. Gulnar
|