CLINICAL EVALUATION OF VISHMUSTHYADI VATI AND KALYANK CHURNA IN THE WITHDRAWAL MANAGEMENT OF TOBACCO CHEWING ADDICTION

Abstract

Background

The global prevalence of tobacco use remains a critical public health challenge, with smokeless tobacco (SLT) consumption, predominantly chewing forms, representing a major public health burden in India. Ayurveda classifies tobacco (Nicotiana tabacum) as a Sthavara Patra Visha (plant-origin poison) , whose properties (Ushna, Vyavayi) induce Vata-Kapha vitiation, leading to neurological and metabolic disturbances analogous to Madatyaya (alcohol-related disorder) and chronic Dushi Visha toxicity. Nicotine dependence is characterized by intense cravings, loss of control, and debilitating physical and psychological withdrawal symptoms. The objective of this study was to assess the clinical efficacy of a novel dual-formulation Ayurvedic regimen Vishmusthyadi Vati (a formulation for systemic detoxification and nerve strengthening) and Kalyank Churna (a polyherbal powder used for internal administration and oral substitution) in mitigating the physical and psychological withdrawal syndrome in patients with tobacco chewing addiction.[i]   

Methods

This investigation employed a prospective, single-arm, open-label, interventional clinical trial design. The study protocol was granted ethical clearance (IEC No.- DSRRAU/PGIAS/IEC/22-23/702) and registered with the Clinical Trials Registry-India (CTRI/2024/07/069867). A cohort of 30 patients (N=30, age range 18–50 years, 96.66% male) diagnosed with chewing tobacco addiction (e.g., khaini, gutka, zarda) completed the 21-day therapeutic intervention. The regimen consisted of combined therapy: Vishmusthyadi Vati (2 vati, 250 mg total, twice daily after meals with lukewarm water) and Kalyank Churna (3g, four times daily, chewed as per need for psychological substitution). The primary outcome measure was the reduction in the severity of withdrawal symptoms, quantified using the Nicotine Withdrawal Scale (NWS) for Tobacco Chewing. Secondary outcomes included systemic biomarkers such as Hemoglobin (Hb), Lipid Profile (HDL, LDL), and Pulse Rate, assessed before and after treatment. Statistical analysis utilized the Wilcoxon matched signed-ranks test for non-parametric data and the Paired t-test for parametric data, with a significance threshold set at P<0.05.   

Results

The 21-day intervention resulted in a highly significant reduction in all measured withdrawal symptoms. The mean total NWS score decreased dramatically from 18.7±3.32 at baseline (categorized as moderate/severe withdrawal) to 6.26±1.08 post-treatment (categorized as mild withdrawal). The overall therapeutic relief achieved was 66.47%, statistically highly significant (P<0.0001). Specific symptoms showing the highest percentage of relief included Constipation (95.88%) and Insomnia (95.14%). Objective analysis demonstrated systemic benefits, including a highly significant increase in Hemoglobin (P<0.0001) and HDL cholesterol (P<0.0001), alongside a significant reduction in LDL cholesterol (P=0.028). No Adverse Drug Reactions (ADR) were reported during the trial duration.   

Conclusion

The combined Ayurvedic regimen of Vishmusthyadi Vati and Kalyank Churna proved safe, well-tolerated, and highly efficacious in the acute management and withdrawal of tobacco chewing addiction. This dual approach successfully addresses both the neurophysiological withdrawal symptoms (Nadibalya action) and the behavioral compulsion (Manasika substitution) , further supported by objective evidence of systemic detoxification (Visha Shamana). The results accept the alternate hypothesis (H1​) that the regimen is effective in the withdrawal of tobacco chewing addiction.