FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091114 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 29/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Unani
Radiation Therapy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study to evaluate Unani drugs in White patches 
Scientific Title of Study   A Comparative Clinical Study on the efficacy of Safuf-i Baras and NB-UVB Phototherapy in 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 Meenu Doni 
Designation  Ph.D. Research Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Moalajat 1st floor room no 2 National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  8792730791  
Fax    
Email  donimeenu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Mohd Aleemuddin Quamri 
Designation  Professor and HOD Dept of Amraz e Jild wa Tazeeniyat 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraz Jild wa Tazeeniyat 2nd floor Room no 3 National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore.

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Meenu Doni 
Designation  Ph.D. Research Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Moalajat 1st floor Room no 2 National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  8792730791  
Fax    
Email  donimeenu@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore 560091 Karnataka India 
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 Meenu Doni  National Institute of Unani Medicine   OPD room no 4 Ground floor National Institute of Unani Medicine Kottigepalya Magadi Main Road Bangalore
Bangalore
KARNATAKA 		 8792730791

donimeenu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee For Biomedical Research  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 
Comparator Agent  Narrowband Ultraviolet B Phototherapy  Patients will be given Narrowband Ultraviolet B phototherapy locally on selected lesions on alternate days up to 60 days 
Comparator Agent  Safuf-i Baras  6gm of Safuf-i Baras in 100 ml of water. It will be given Orally in the form of Zulal(decanted liquid) and sediment mixed with Sirka Naishkar (Vinegar) will be applied on selected lesion followed by exposure to sunlight for 20 minutes for 60 days 
Intervention  Safuf-i Baras and Narrowband Ultraviolet B Phototherapy   Orally, Zulal only daily followed by exposure to Narrowband Ultraviolet B phototherapy locally on selected lesions on alternate days for 60 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of Non-Segmental Vitiligo,any gender and age group from 18-50years.
• Subjects with disease chronicity between 6 months to 2 years
Subjects with less than or equal to 2 percent Body Surface Area (BSA)
Subjects fulfilling the Vitiligo Extent Tensity Index (VETI) score up to a grade of
tensity plus 3
Subjects who have not been taken any treatment in the past 2 weeks  
 
ExclusionCriteria 
Details  Subjects with Mucosal and Universal variants NSV
Subjects with Segmental Vitiligo/ Lip-Tip vitiligo
Subjects with history of photosensitivity/photo-exaggerated dermatoses.
Pregnant and Lactating Women
Patients suffering from systemic, metabolic and other autoimmune diseases.
Patients suffering from skin conditions like psoriasis, tinea, alopecia areata, halo
nevus, pityriasis alba, melanoma and morphea.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Vitiligo Extent Tensity Index (VETI) Reduction in Vitiligo Area Scoring Index (VASI)  At baseline, 15th day, 30th day, 45th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Quality of life in Vitiligo patients using DLQI (Dermatology Life Quality Index  At baseline and on last follow up (60th day) 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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
Modification(s)  		 Vitiligo is a skin condition characterized by the loss of melanocytes, leading to hypopigmentation and white patches. It can occur at any age but is most common in individuals during their 20s and 30s, affecting all ethnicities and genders. The prevalence of vitiligo ranges from 0.1 percent to 2 percent globally and can cause significant psychological distress, including anxiety and depression. The exact cause of vitiligo remains unclear, with various factors such as autoimmune reactions and oxidative stress implicated in melanocyte destruction. Treatment options include medical therapies like topical steroids and phototherapy, though these can have adverse effects. Unani medicine offers a range of treatments for vitiligo, with specific herbs and compounds noted for their potential efficacy. Historical figures like Ibn Sina have advocated for sunlight exposure as beneficial, aligning with modern treatments like Narrow Band UVB phototherapy. therefore, a clinical study is planned to investigate the effectiveness of the Unani formulation Safuf-i Baras combined with NB-UVB phototherapy for treating vitiligo. 
Close