A Two Arm, Open Label, Randomized, Multi centric, Interventional, Prospective, Clinical Study to Evaluate Efficacy and Safety of Nicotine Free Ayurvedic Formulation (SMOTECT-AZAADI granules) in comparison with Nicotine Replacement Therapy (NRT) in Tobacco users (Chewing)

BackgroundSmokeless tobacco (SLT) poses a major public health risk, linked to cancer, heart disease, and stroke. Nicotine Replacement Therapy (NRT) is commonly used for tobacco cessation. However, it carries a high risk of relapse, which significantly limits its long-term effectiveness. Nicotine free Ayurvedic formulations (NFAF), having potential anti-stress and mood enhancing properties may offer a healthier promising alternative. PurposeThe study evaluated the efficacy and safety of the proposed Nicotine free Ayurvedic formulation compared to NRT in tobacco chewers. MethodsA two-arm, open-label, randomized, multicentric clinical trial involving 112 participants was conducted with one group receiving NFAF and the other NRT for 90 days with follow ups every 15 days till day 90 and a follow up on day 120 after 30 days of non intervention. Parameters such as frequency, duration of tobacco/gutka usage to evaluate dependency on nicotine, mouth opening capacity, quality of life, physiological measures and clinical symptoms were assessed. Safety assessment was also done based on clinical and laboratory parameters. ResultsThe proposed Nicotine free Ayurvedic formulation was observed to be as effective as NRT in reducing tobacco consumption and dependence. Significant and comparable reduction in stress, fatigue and improvement in energy strength, stamina and well-being were observed with the use of NFAF. Clinical symptoms such as headache, fatigue, and mood changes improved similarly in both groups. A higher percentage of NFAF users (21.56%) achieved complete cessation of tobacco consumption versus NRT users (17.77%). NFAF was observed to be well tolerated, with only minor, self-limiting adverse events. ConclusionNFAF effectively reduced SLT dependence and improved quality of life and clinical symptoms, with good safety. It represents a healthier alternative for tobacco cessation.