A Randomised Trial of Madhuyashtyadi Granules vs Nicotine Chewing Gum with Mind–Body Interventions for Tobacco DeAddiction in School Children

Tobacco use among rural Indian adolescents is increasing, raising risks of non-communicable diseases. This trial compared an Ayurvedic polyherbal formulation, Madhuyashtyadi Granules (MG), combined with mind-body interventions, to standard Nicotine Chewing Gum (NCG) with similar supports. In a two-year open-label randomized trial, 52 male schoolchildren with ≥6 months of smokeless tobacco use were assigned to MG (n=25) or NCG (n=27) arms. Both groups received weekly tapering, daily meditation, Sattvavajaya counselling, and ethical conduct training. Ayurveda, India’s traditional medical system, prescribes Sattvavajaya Chikitsa (SC) for mind control, Sadvritta (ethical conduct guidance) for lifestyle modification, and Rasayana and Vishahara herbs for detoxification. Primary outcomes were reductions in urinary cotinine and daily sachet use; secondary outcomes included craving frequency, withdrawal symptoms, appetite, and well-being. At 3 months, MG users had greater cotinine reduction (31% vs. 19%), and 44% achieved complete cessation versus 0% in the NCG group. MG users also had greater reductions in cravings and withdrawal symptoms (p<0.05). Findings support Ayurvedic interventions as a culturally congruent and effective alternative for paediatric tobacco de-addiction. The Ayurvedic multimodal regimen, including MG demonstrated superior efficacy over standard NRT in reducing tobacco use, cravings and toxic exposure. Limitations were singlegender sampling necessitate cautious interpretation. Larger, double-blind, multi-centric trials with diverse cohorts are recommended.