An open-label, randomized, parallel-group, active-controlled clinical trial protocol to evaluate the efficacy and safety of Astangalavana and Srikhandasava as add-on Ayurvedic interventions in alcohol dependence (Madatyaya)

Abstract BACKGROUND: Madatyaya (alcohol dependence) is a complex psychosomatic disorder with significant public health implications. Conventional pharmacotherapy, including anti-craving agents like Acamprosate, has shown limited success in sustaining abstinence. Ayurvedic formulations such as Astangalavana and Srikhandasava , mentioned in classical texts, are traditionally used for managing symptoms associated with alcohol use disorders. The objective of the study was to evaluate the efficacy and safety of Astanga Lavana and Srikhandasava as an add-on to the management of Madatyaya (alcohol dependence). MATERIALS AND METHODS: The study is being conducted as an open-label clinical trial at the Center for Addiction Medicine, National Institute of Mental Health and Neuro Sciences, Bengaluru. A total of 200 male participants aged 18–60 years and diagnosed with alcohol dependence as per ICD-10 are being randomly assigned to two groups. The control group is being treated with Acamprosate doses ranging from 333 to 666 mg orally thrice daily based on the clinical judgment for 90 days. The intervention group is being treated with Acamprosate along with Astangalavana (3 g twice daily with lukewarm water) and Srikhandasava (20 mL twice daily with equal potable water) for 90 days. Primary outcomes include percentage of abstinent days assessed by the timeline follow-back method, urinary ethyl glucuronide/ethyl sulfate, and breath alcohol analysis. Secondary outcomes include changes in alcohol craving using the Penn Alcohol Craving Scale, quality of life via WHOQOL-BREF, and serum gamma-glutamyl transferase levels. Safety will be monitored using adverse event tracking and liver function tests. CONCLUSION: This clinical trial protocol explores an integrative approach to managing alcohol dependence ( Madatyaya ) by assessing the efficacy and safety of two classical Ayurvedic formulations— Astangalavana and Srikhandasava —as adjuncts to Acamprosate. Using psychometric assessments, biochemical markers, and standardized outcomes, the study aims to generate robust evidence to support the integration of Ayurveda into conventional clinical management of substance use disorders. TRIAL REGISTRATION: CTRI/2019/10/021831 dated October 31, 2019, last modified on March 09, 2021.