Abstract:
Background and Objective: Alcoholism (alcohol dependence) is a chronic illness
marked by dependence on alcohol consumption. It interferes with health, social as
well as family life and job responsibilities. Based on the experience of an observational
single‑arm study with positive outcomes, this protocol is being implemented to compare
the effectiveness of homoeopathic intervention with standard allopathic treatment.
Materials and Methods: This will be a randomized controlled open‑label comparative
trial. Patients will be randomized to receive either Homoeopathy or Allopathy group of
intervention using computerized randomization chart. The period of treatment cum follow
up shall be for 1 year. Supportive counseling shall be given to both the groups. Primary
outcome will be more than 50% reduction in ‘Severity of Alcohol Dependence (SADQ)’
rating scale in comparison to baseline at the exit of treatment of 1 year and
secondary outcomes will comprise of changes in World Health Organisation quality
of life -BREF(WHOQOL-BREF) at baseline and at end of the study, management of
detoxification shall be done using Clinical Institute Withdrawal Assessment for Alcohol
Scale, Revised (CIWA‑Ar). Further changes in alcohol consumption pattern in terms of
quantity and frequency shall be assessed.
Discussion: The study shall help in designing further rigorous randomized controlled
trial (RCT)/pragmatic study with homoeopathic intervention.
