A prospective, randomized, parallel-group, comparative clinical trial to evaluate the combined efficacy of Gandhaka Rasayana and Vachadi Lepa compared to standard treatment in the management of Pama (Scabies) in children: A study protocol of a pilot

Abstract BACKGROUND: Scabies, a common dermatological condition in tropical climates like India, disproportionately affects children, particularly in settings with close contact, high humidity, and overcrowding. Despite its public health significance, underreporting remains a concern. This study aims to evaluate the combined efficacy of Gandhaka Rasayana (GR), a herbo-mineral formulation administered orally, and Vachadi Lepa (VL), a polyherbal topical application, compared to permethrin 5% ointment as the standard treatment in children with scabies. MATERIALS AND METHODS: This randomized, controlled trial will include 20 participants in each group, aged 6–16 years, of both genders. Participants diagnosed with Pama (scabies) will be recruited from the outpatient department of Kaumarbhritya (Pediatrics) JSS Ayurveda College Mysuru and through camps based on predefined inclusion criteria. Subjects with systemic disorders or known allergies to sulfa drugs will be excluded. The intervention group will receive GR orally for 14 consecutive days in age-specific dosages: 500 mg twice daily for participants aged 6–10 years and 1 g twice daily for those aged 11–16 years. VL will be applied externally as a thick paste (sufficient quantity for thick Lepa ). The control group will receive permethrin 5% ointment, applied once weekly over the lesions as the standard treatment. Assessments will be conducted on the 7th and 15th days during the intervention and on the 29th day as a follow-up. The study will evaluate changes in clinical features and scabies-specific quality of life parameters. Statistical analysis will be performed using the Wilcoxon signed-rank test and Mann–Whitney U test, with a significance level set at P ≤ 0.05. DISCUSSION: The findings are expected to provide evidence-based insights into the potential of Ayurvedic interventions as a well-tolerated and effective alternative for pediatric scabies management. TRIAL REGISTRATION: The trial is prospectively registered with the Clinical Trial Registry of India (CTRI/2023/08/055938), registered on August 1, 2023.