CTRI Number |
CTRI/2018/04/013349 [Registered on: 18/04/2018] Trial Registered Retrospectively |
Last Modified On: |
|
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Non-randomized, Multiple Arm Trial |
Public Title of Study
|
Treatment of white patches with Unani formulations |
Scientific Title of Study
|
An open label pilot study to evaluate safety and efficacy of Unani formulations (coded) PTV-6, PTV-7 (oral) and TA-1 AND TA-1 plus (topical) in Vitiligo patients of different skin grades |
Trial Acronym |
PS/PP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Farhat Jabeen |
Designation |
Research Officer (U) |
Affiliation |
Central Research Institute of Unani Medicine |
Address |
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9032280109 |
Fax |
|
Email |
fjabeen244@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Muawwar Husain Kazmi |
Designation |
Director I/C |
Affiliation |
Central Research Institute of Unani Medicine |
Address |
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9030168455 |
Fax |
|
Email |
criumhyderabad@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Muawwar Husain Kazmi |
Designation |
Director I/C |
Affiliation |
Central Research Institute of Unani Medicine |
Address |
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9030168455 |
Fax |
|
Email |
criumhyderabad@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Unani Medicine, 61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi, Delhi 110058 |
|
Primary Sponsor
|
Name |
Central Council for Research in Unani Medicine |
Address |
Central Council of Research in Unani Medicine 61-65, Institutional
Area Opp. D-Block, Janakpuri New Delhi – 110 058 |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Farhat Jabeen |
Central Research Institute of Unani Medicine |
Room no - 1, Bars ROPD Unit-1,
8-3-168/A/1/UM, A.Gs Colony Road, Erragadda Hyderabad ANDHRA PRADESH |
9032280109
fjabeen244@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, CRIUM, Hyderabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Vitiligo, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group A: PTV-6 and PTV-7 oral,
TA 1 local application |
Oral administration:
The systemic treatment drugs P.T.V-6 (oral-500mg each) in the dose of 1 TID after food and P.T.V-7 (Oral -500mg each) in the dose of 1 BD before food is given for 25 days in a month followed by 5 days gap in each month as specific wash-out period.
Topical application:
The topical application of TA 1 for subjects with skin grade 1 & 2 in the form of ointment will be applied and exposed to sun light for 3-15 minutes. The exposure time to sun light will be adjusted according to the skin sensitivity of an individual which could range from 3-15 minutes.
Total Duration of the Treatment: 6 months |
Intervention |
Group B: PTV-6 and PTV-7 oral, TA-1 Plus for local application |
The systemic treatment drugs P.T.V-6 (oral-500mg each) in the dose of 1 TID after food and P.T.V-7 (Oral -500mg each) in the dose of 1 BD before food is given for 25 days in a month followed by 5 days gap in each month as specific wash-out period.
The topical application of TA 1 plus for subjects with skin grade 3 in the form of ointment will be applied and exposed to sun light for 3-15 minutes. The exposure time to sun light will be adjusted according to the skin sensitivity of an individual which could range from 3-15 minutes.
Total Duration of the Treatment: 6 months |
Comparator Agent |
nil |
nil |
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Known cases of Vitiligo with any duration of disease, site, extension and distribution of vitiligenous lesions.
2. Either sex, age range 13–50 years, with or without family history.
3. Willingness to participate in the study and to give written informed consent.
|
|
ExclusionCriteria |
Details |
1. Subjects having any systemic disease and other skin diseases.
2. Subjects with known allergies.
3. Impaired Cardiac, Hepatic and Renal function
4. Use of any other medications of allopathic and alternative system origin for the disease.
5. Concomitant use of any other antioxidants
6. History of hypersensitivity to any of the investigational drugs/herbal medicine.
7. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.
8. Pregnant and lactating women. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
By observation and Digital photography. |
Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Pathological and Biochemical Investigations for safety measures. |
Before treatment and after treatment |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
09/08/2014 |
Date of Study Completion (India) |
30/09/2016 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Vitiligo is a complex metabolic disorder characterized by loss of pigmentation which is polygenic in nature and mostly regarded as social stigma. The course of Vitiligo without treatment is unpredictable. As Vitiligo being most stubborn, resistant cosmetic problem, it needs more attention. Skin sensitivity is genetically predisposed which is usually graded as most sensitive to resistant. Among the subjects with skin grade 1 and 2 the topical application of Unani formulation causes sensitivity problems which ranges from hyperemia, itching, burning, blister formation, etc., which needs formulation that can be well tolerated. There is a need to focus on two issues one in combating the origin of disease and the other is to induce the re-pigmentation. The treatment options available across the systems have their own limitation in offering relief to this cosmetic problem. The incidence of side effects are too high as reported both with topical as well as systemic therapy, at the same time the surgical options available are self-hazardous unless disease become stable and there is hardly any medication available in the modern medicine to control the disease process and to check the aggravation. The steroids and PUVA therapy which are usually employed for the above purpose are Hepato-toxic and carcinogenic in the prolong use. |