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

INTERVENTION: 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. 6. 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 7. 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 CONDITION: vitiligo PRIMARY OUTCOME: 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. 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: None []; 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