Potential implications of a therapeutic polyherbal infusion in Ayurveda as an adjunct to multidisciplinary relaxing techniques in alcohol withdrawal syndrome-an exploratory randomized study protocol.

BACKGROUND

Alcohol withdrawal syndrome (AWS) constitutes a critical clinical outcome across the spectrum of alcohol use disorders (AUD), comprising severe neuropsychological manifestations during early abstinence among individuals with alcohol dependence. Pharmacological management primarily relies on benzodiazepines, which may cause dependence and hepatic stress. Addressing the core psychological domains is essential for uplifting the quality of life in such patients, and an integrated psychopharmacological approach rooted in holistic principles would be prioritized for better recovery. Ayurveda believes in treating the root cause rather than the symptoms, and hence, a polyherbal formulation is used in this trial, which would act on the doshas (humors) responsible for the manifestation of AWS. Hence, integrating the therapeutic intake of Kharjuradi Mantha coupled with mind-body relaxation interventions could provide substantial symptom control and enhanced recovery outcomes.

OBJECTIVES

This exploratory randomized study protocol aims to evaluate the efficacy of a therapeutic herbal infusion (Kharjuradi Mantha) as an adjunct to multidisciplinary relaxation techniques comprising yoga, meditation, and counseling in individuals experiencing mild-to-moderate AWS.

METHODS

An exploratory, open-label, parallel-group randomized controlled trial will be conducted among 38 male inpatients who are diagnosed with mild-to-moderate AWS (Clinical Institute Withdrawal Assessment for Alcohol-Revised [CIWA-AR] score 8-15). Participants will be randomly assigned in a 1:1 ratio to receive either the herbal infusion in addition to relaxation techniques or the relaxation techniques alone for 28 days. The major outcome measure is to evaluate the difference in CIWA-AR scores from baseline to the 29th day after the completion of the trial in the trial setting.

EXPECTED OUTCOMES: It is anticipated that the herbal infusion will enhance symptom resolution and overall psychological stability, which is reflected in the CIWA-AR scores when combined with yoga, meditation, and counseling, compared with standard non-pharmacological management alone.

CLINICAL TRIAL REGISTRATION: https://ctri.nic.in, Identifier CTRI/2024/07/070952.