An Open Label Single Arm Clinical Study to Evaluate the Efficacy of Tumburu (Zanthoxylum Armatum Dc.) in Tobacco Chewing Addiction

Abstract

India is the second largest tobacco producing nation and the second largest consumer of tobacco worldwide. The World Health Organization classifies tobacco addiction as a chronic condition driven by nicotine dependence, which creates a complex cycle of physical and psychological dependence. Aim and Objectives– To evaluate the clinical efficacy of Tumburu (Zanthoxylum armatum DC.) in tobacco chewing addiction. The objectives were to develop an ayurvedic remedy for reduction in the harmful effects of nicotine and to introduce an alternative replacement drug therapy. Methods– Based on inclusion and exclusion criteria, total 40 tobacco addicted individuals were selected irrespective of their gender, caste or creed. It was an Open Label Single Arm Clinical Trial which was conducted for 2 months. Fruit pericarp of Tumburu was given 4-5 times a day when there was an urge to chew tobacco. It was kept in the oral cavity. The data was recorded and evaluated through the subjective and objective parameters. Statistical analysis– Wilcoxon signed ranked test was applied for subjective parameters and Paired t-test was applied for objective parameters. Result– The overall response to the treatment with Tumburu in addicted individuals were statistically significant. 20% had marked improvement, 14.29% had moderate improvement, 37.14% had mild improvement and 28.57% had no improvement. Conclusion– This study provides the clinical validation for the effectiveness of Zanthoxylum armatum in tobacco chewing addiction and contributed and provided support to quit tobacco’s use for better health outcomes.