Home » Trials » SLCTR/2026/020
Comparative clinical, immunological and phytochemical evaluation of Limonia acidissima and Brahmiyadi decoctions in managing vitiligo (Svitra) among patients at Gampaha Wickramarachchi teaching hospital, Yakkala, Sri Lanka.
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SLCTR Registration Number
SLCTR/2026/020
Date of Registration
The date of last modification
Aug 03, 2026
Scientific Title of Trial
Comparative clinical, immunological and phytochemical evaluation of Limonia acidissima and Brahmiyadi decoctions in managing vitiligo (Svitra) among patients at Gampaha Wickramarachchi teaching hospital, Yakkala, Sri Lanka.
Public Title of Trial
A study comparing Limonia acidissima and Brahmiyadi herbal decoctions for improving skin repigmentation and serum IL-6 and TNF-? levels in patients with vitiligo at Gampaha Wickramarachchi Ayurveda Teaching Hospital, Sri Lanka
Disease or Health Condition(s) Studied
vitiligo
Scientific Acronym
None
Public Acronym
None
Brief title
Herbal Decoctions for Vitiligo Management
Universal Trial Number
U1111-1333-5168
Any other number(s) assigned to the trial and issuing authority
Ethics Review Committee of the Faculty of Medicine, University of Kelaniya (Ref No: P/127/09/2024).
What is the research question being addressed?
Which of the two decoctions, Limonia acidissima or Brahmiyadi, is more effective in improving clinical outcomes and modulating immunological markers in patients with Vitiligo (Svitra)
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2
Intervention(s) planned
Study setting Gampaha Wickramarachchi Ayurveda Teaching Hospital, Yakkala, Sri Lanka.
Randomization a. Method of randomization into study arms Simple randomization using a chit-based (lottery) method. b. Unit of randomization Individual patient. c. Method of sequence generation Random allocation sequence was generated using a chit-based (lottery) method. d. Method of allocation concealment Allocation was concealed using identical, opaque, folded chits containing group assignments, which were thoroughly mixed and drawn blindly at the time of participant enrollment.
Intervention Arm 1: Limonia acidissima Decoction • Type: Herbal/Traditional Medicine • Formulation: Freshly prepared decoction of Limonia acidissima • Dose: 120 mL • Route: Oral • Frequency: Twice daily before meals • Duration: 90 days • Preparation: Standard Kashaya method (1 part plant material boiled in 8 parts water and reduced to 1 part)
Control Arm 2: Brahmiyadi Decoction (Active Comparator) • Type: Herbal/Traditional Medicine • Formulation: Polyherbal Brahmiyadi decoction • Dose: 120 mL • Route: Oral • Frequency: Twice daily before meals • Duration: 90 days
Brahmiyadi decoction is not a formally established standard therapy; however, it is a routinely used clinical preparation in the management of vitiligo (?vitra) at the study setting and is used in this study as an active comparator.Both study arms receive active herbal interventions. This study is designed as a comparative evaluation between two routinely used decoctions, with no placebo or untreated control group.
All participants in both groups will receive standard supportive care, including: • Ayurvedic dietary and lifestyle advice • No concurrent systemic or topical anti-vitiligo medications will be permitted during the study period
Blinding This is an open-label study. • Participants: Not blinded • Healthcare providers: Not blinded • Data collectors: Not blinded • Outcome assessors: Not blinded • Data analysts: Not blinded
Inclusion criteria
• Patients aged 18–65 years • Male and female patients • Clinically diagnosed cases of vitiligo presenting with white depigmented patches • Duration of disease ? 1 year
Exclusion criteria
Primary outcome(s)
|
1.
Metric / Method of Measurement: VASI (Vitiligo Area Scoring Index) or VESS (Vitiligo Extent Score). This involves a physical examination by a clinician to calculate the area of depigmentation. |
[ Baseline (Day 0) and End of Treatment (Day 90). ] |
|
2.
Metric / Method of Measurement: ELISA (Enzyme-Linked Immunosorbent Assay) to measure specific markers like TNF-?, IL-10, or IFN-?. |
[ Baseline (Day 0) and Day 90. ] |
Secondary outcome(s)
|
1.
None |
[] |
Target number/sample size
30 in each group
Countries of recruitment
Sri Lanka
Anticipated start date
2025-08-10
Anticipated end date
2027-01-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
self-funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2025-02-10
Approval number
p/127/09/2024
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Kelaniya. |
| Institutional Address: | Faculty of medicine, university of kelaniya, Ragama. |
| Telephone: | 0112961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Shazmin hazari
Ayurveda medical officer
University of kelaniya
0712452855
fathimashein@gmail.com
Contact Person for Public Queries
Dr. J.A.D. P. P Jayakody
Senior Lecturer
Department of Cikitsa, Faculty of Indigenous Medicine, Gampaha Wickramarachchi University of Indigenous Medicine, Yakkala, Sri Lanka
0712452855
pushpaj@gwu.ac.lk
Primary study sponsor/organization
Gampaha Wickramarachchi Ayurveda Teaching Hospital
32RP+FQ6, Kandy - Colombo Rd, Yakkala
0332 239 988
https://gwu.ac.lk/index.php/indigenous-medicine
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results