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CTRI Number  CTRI/2026/03/106133 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to Test if Applying Babchi Oil Helps Restore Skin Color in Patients with Vitiligo 
Scientific Title of Study   Efficacy and Safety of Topical Babchi Oil as an Adjuvant Therapy in Vitiligo: A Randomized Placebo-Controlled Clinical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sai Shiva Ram 
Designation  Postgraduate 
Affiliation  Saveetha medical college and hospital,saveetha institute of medical and technical sciences 
Address  Depatment of dermatology [4th floor],Saveetha Medical College,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 Kancheepuram, TAMIL NADU Kancheepuram TAMIL NADU 602105 India

Kancheepuram
TAMIL NADU
602105
India 
Phone  9000980253  
Fax    
Email  medasaishivaram@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varun Rajagopal 
Designation  Assistant Professor 
Affiliation  Saveetha medical college and hospital,saveetha institute of medical and technical sciences 
Address  Depatment of dermatology [4th floor],Saveetha Medical College,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 Kancheepuram, TAMIL NADU Kancheepuram TAMIL NADU 602105 India

Kancheepuram
TAMIL NADU
602105
India 
Phone  8610424075  
Fax    
Email  drvarunrajagopal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sai Shiva Ram 
Designation  Postgraduate 
Affiliation  Saveetha medical college and hospital,saveetha institute of medical and technical sciences 
Address  Depatment of dermatology [4th floor],Saveetha Medical College,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 Kancheepuram, TAMIL NADU Kancheepuram TAMIL NADU 602105 India

Kancheepuram
TAMIL NADU
602105
India 
Phone  9000980253  
Fax    
Email  medasaishivaram@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical College,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 Kancheepuram, TAMIL NADU Kancheepuram TAMIL NADU 602105 India 
 
Primary Sponsor  
Name  Sai Shiva Ram M 
Address  Saveetha medical college and hospital,saveetha nagar,thandalam,chennai 602105 
Type of Sponsor  Other [self] 
 
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 Sai Shiva Ram M  saveetha medical college and hospital  Depatment of dermatology [4th floor],Saveetha Medical College,Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 Kancheepuram, TAMIL NADU
Kancheepuram
TAMIL NADU 
9000980253

medasaishivaram@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
saveetha medical college and hospital instituitional ethics committee  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  Babchi Oil  The intervention group received topical Babchi oil application twice daily for 12 weeks. 
Comparator Agent  PLACEBO OIL   THE PLACEBO GROUP RECEIVED A VISUALLY AND TEXTURALLY IDENTICAL CARRIER OIL DEVOID OF ACTIVE PHYTOCONSTITUENTS,APPLIED WITH THE SAME FREQUENCY AND DURATION 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age and Gender: Male or female patients aged 18 to 60 years,Clinically confirmed cases of stable, localized Non-Segmental Vitiligo (NSV) 
 
ExclusionCriteria 
Details  . Exclusion criteria comprised a known history of hypersensitivity to Psoralea corylifolia preparations, pregnancy or lactation, use of systemic immunosuppressive therapy within the preceding three months, and the presence of other autoimmune or inflammatory skin disorders. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Vitiligo Extent Tensity Index (VETI) score from baseline to week 12 to assess improvement in vitiligo severity.  Clinical assessments were performed at baseline (week 0) and after completion of the treatment period (week 12)  
 
Secondary Outcome  
Outcome  TimePoints 
Repigmentation grade (poor, moderate, marked, excellent)
Lesion extent score
Lesion intensity score
Patient satisfaction
Safety/adverse events 
Clinical assessments were performed at baseline (week 0) & after completion of the treatment period (week 12)  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   23/03/2026 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   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  

Vitiligo is a chronic depigmenting disorder characterized by loss of melanocytes resulting in depigmented patches on the skin. Although several treatment modalities are available including topical corticosteroids and phototherapy, consistent and sustained repigmentation remains difficult to achieve in many patients. Babchi oil derived from the seeds of Psoralea corylifolia has been traditionally used for pigmentary disorders and contains bioactive compounds that may stimulate melanocyte activity and promote repigmentation.

The present study aims to evaluate the efficacy and safety of topical Babchi oil as an adjuvant therapy in patients with vitiligo. In this randomized placebo controlled clinical study, forty patients with clinically diagnosed vitiligo will be enrolled and randomly allocated into two groups. The intervention group will receive topical Babchi oil applied twice daily for twelve weeks while the control group will receive placebo oil with identical appearance and application schedule.

Clinical outcomes will be assessed using validated scoring systems including Vitiligo Extent Tensity Index and physician global assessment along with patient satisfaction scores. Safety will be evaluated by monitoring adverse events during the study period.

The hypothesis of the study is that topical Babchi oil used as an adjuvant therapy can significantly enhance repigmentation in vitiligo lesions compared to placebo while maintaining a favorable safety profile.

 
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