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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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