Assessing the Efficacy of Oral Administration of Triphala, Vacha, and Musta Combination Tablet in Childhood Obesity (Sthaulya):A Double-Blind, Placebo-Controlled Randomized Trial

This study is a randomized double blind placebo controlled prospective clinical trial designed to evaluate the efficacy of oral administration of Triphala Vacha and Musta combination tablet in the management of childhood obesity Sthaulya. The study will be conducted at the Department of Kaumarabhritya and Bala Roga All India Institute of Ayurveda New Delhi and will include 70 children aged 6 to 16 years diagnosed with obesity as per Extended Indian Academy of Pediatrics BMI charts. Participants will be randomly allocated into two groups of 35 each. The intervention group will receive Triphala Vacha and Musta combination tablets prepared in Ghana form administered orally in two divided doses before meals with lukewarm water for a duration of 60 days along with standard lifestyle recommendations while the control group will receive identical placebo tablets with the same schedule and lifestyle advice. Randomization will be computer generated and double blinding will be maintained for participants investigators and outcome assessors until completion of data analysis. The primary outcome measure is reduction in body mass index at the end of 60 days and secondary outcome measures include changes in body weight waist circumference skinfold thickness and Ayurvedic symptom score of Sthaulya. Safety will be monitored throughout the study and any adverse drug reactions will be documented and reported as per institutional pharmacovigilance guidelines. Written informed consent from parents or legal guardians and assent from children will be obtained prior to participation and the study will be initiated only after approval from the Institutional Ethics Committee and registration with the Clinical Trials Registry of India