| 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
|
|
|
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
|
|
|
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. |