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CTRI Number  CTRI/2025/03/081572 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   clinical study to evaluate the safety and efficacy of Dimad e baras in baras (Vitiligo) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of Dimad-E- Baras (Topical) Compared With Methoxasalen 1 Percent(Topical) In The Management Of Baras (Vitiligo) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hina Kausar 
Designation  PG Scholar  
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute Of Unani Medicine For Skin Disorders Department of Moalajat AG Colony Road, opp. ESI Hospital, Erragadda, 500038 Hyderabad Telangana

Hyderabad
TELANGANA
500038
India 
Phone  7972260177  
Fax    
Email  hinakausarhd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashfaque Ahmed 
Designation  Reader 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute Of Unani Medicine For Skin Disorders Department of Moalajat AG Colony Road, opp. ESI Hospital, Erragadda, 500038 Hyderabad Telangana

Hyderabad
TELANGANA
500038
India 
Phone  8103161174  
Fax    
Email  drashfaque6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hina Kausar 
Designation  PG Scholar  
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute Of Unani Medicine For Skin Disorders Department of Moalajat AG Colony Road, opp. ESI Hospital, Erragadda, 500038 Hyderabad Telangana


TELANGANA
500038
India 
Phone  7972260177  
Fax    
Email  hinakausarhd@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders AG Colony Road, Opp. ESI Hospital, Erragadda, 500038 Hyderabad 
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  A.G. Colony Road, Opposite E.S.I. Hospital,Erragadda, Hyderabad-500038 
Type of Sponsor  Research institution and hospital 
 
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 Hina Kausar  National Research Institute of Unani Medicine for Skin Disorders   OPD and IPD of NRIUM SD ,Department of Moalajat, A.G.Colony Road, Opposite E.S.I. Hospital, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA 
7972260177

hinakausarhd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Dissertation of Institutional Ethics Committee(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dimad-e-Baras  Dimad-e-Baras containing Bekh-e-Anjeer Dashti, Babchi ,Tukhm-e-Panwar, Narkachor ,Abe lemu will be used topically on vitiliginous lesions followed by sun exposure daily once. 
Comparator Agent  Methoxsalen 1 % Solution  Apply Methoxsalen 1 % Solution topically on vitiliginous lesions followed by sun exposure.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants having Non segmental vitiligo with Chronicity of 6 months to 3 years
2.Vitiligo involving more than 2 percent Body Surface Area (BSA)
3.Participants with less than 5 new lesions in the last month
4.Participants with less than 15 lesions in the last 3 months
5.Participants who have not taken systemic and tropical treatment in the last 4 week
 
 
ExclusionCriteria 
Details  1.Participants aged less than 18 years or more than 60 years
2.Participants with Segmental vitiligo/acrofacial vitiligo/mucosal vitiligo and vitiligo universalis
3.Participants with history of any other skin disorders and inflammatory condition of the skin
4.Pregnant or Lactating Women
5.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction
6.Known cases of Diabetes Mellitus
7.Known cases of Immunocompromised states
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change In Vitiligo Area Scoring Index (VASI)  0,2,4 and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in Patient’s Global Assessment (PGA) on VAS for Vitiligo
2.Improvement in Investigator’s Global Assessment (IGA) for Vitiligo
3.Improvement in QoL on VIS-22
(Assessment of Patient’s Quality of Life)
 
0 and 8 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   01/05/2025 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Baras (Vitiligo) is a skin disorder caused by the destruction of melanocytes, leading to depigmented patches. It affects 1%–2% of the global population and 3%–4% in India. Conventional treatments, such as medications or surgical procedures, often have limited effectiveness, side effects, and high costs. Unani medicine offers accessible and cost-effective alternatives. Dimad-e-Baras a polyherbal Unani formulation, is proposed to stimulate regimentation in vitiligo patients. A clinical trial is planned to scientifically evaluate its safety and efficacy, aiming to establish Dimad-e-Baras as a viable and affordable alternative to conventional vitiligo therapies.

 
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