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

03 Aug 2026

The date of last modification

Aug 03, 2026



Application Summary


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).


Trial Details


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

  1. Study setting Gampaha Wickramarachchi Ayurveda Teaching Hospital, Yakkala, Sri Lanka.

  2. 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.

  3. 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)

  4. 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.

  1. 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

  2. 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

  • Vitiligo patches that are confluent (combined).
  • Patches located near the natural orifices, or on the fingers (distal ends of the upper and lower extremities).
  • Patches involving more than one-third of the total body surface area.
  • Vitiligo patches resulting from injury or burns.
  • Vitiligo associated with exposure to phenolic or other chemical compounds.
  • Patches caused by prolonged pressure from clothing or other wearing apparel.
  • History of cardiovascular diseases (e.g., myocardial infarction or ischemic heart disease).
  • Major systemic illnesses, including acute or chronic renal failure.
  • Untreated thyroid disorders.
  • Current alcohol dependence, occasional alcohol consumption, or use of narcotic drugs.
  • Other dermatological disorders, including hypersensitivity skin conditions.
  • Pregnant or lactating women.
  • Patients currently using any internal or external medication for vitiligo during the study period.


Primary outcome(s)

1.
  1. Percentage of Skin Repigmentation.

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.
  1. Change in Serum Cytokine Levels.

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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