Efficacy of melatonin add-on to treatment-as-usual in treatment of alcohol withdrawal.

A randomized controlled trial to assess the safety and efficacy of melatonin add-on to treatment-as-usual compared to treatment-as-usual in treatment of alcohol withdrawal in individuals with alcohol dependence - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093624

Enrollment

782

Registered

2025-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: Tab. Melatonin 5mg: Oral Melatonin Tablet 5mg once a day at bedtime in addition to the standard treatment for 7 consecutive days from day of admission. For those who are in control arm

Eligibility

Inclusion criteria

Inclusion criteria: Age 18-50 yrs more than 10 score (moderate severity) CIWA-Ar score Able to give consent for study

Exclusion criteria

Exclusion criteria: Old Age (more than 50years) Secondary insomnia due to other medical/ surgical/ psychiatric conditions (other medical cand surgical conditions which might cause insomnia) Patients in Delirium tremens at presentation

Design outcomes

Primary

Measure	Time frame
Duration and severity (CIWA) of alcohol withdrawal compared to treatment as usual in patients with alcohol dependence. Sleep parameters as assessed by a wrist worn sleep tracker. Cumulative dose of benzodiazepines for detoxification and antipsychotics for agitation. Timepoint: Assessments will be made everyday for 7 consecutive days. Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7.	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactB C MALATHESH

ALL INDIA INSTITUTE OF MEDICAL SCIENCES - BIBINAGAR.

bc.malathesh@gmail.com918806406530

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026