FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093624 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 11/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Other (Specify) [Melatonin - Harmone]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of melatonin add-on to treatment-as-usual in treatment of alcohol withdrawal. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B C MALATHESH 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES - BIBINAGAR. 
Address  Room 13 Department of Psychiatry, First floor AIIMS Bibinagar Rangapur Village, Bibinagar Bhongir District Telangana

Hyderabad
TELANGANA
508126
India 
Phone  918806406530  
Fax    
Email  bc.malathesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  B C MALATHESH 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES - BIBINAGAR. 
Address  Room 13 Department of Psychiatry, First floor AIIMS Bibinagar Rangapur Village, Bibinagar Bhongir District Telangana


TELANGANA
508126
India 
Phone  918806406530  
Fax    
Email  bc.malathesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  B C MALATHESH 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES - BIBINAGAR. 
Address  Room 13 Department of Psychiatry, First floor AIIMS Bibinagar Rangapur Village, Bibinagar Bhongir District Telangana


TELANGANA
508126
India 
Phone  918806406530  
Fax    
Email  bc.malathesh@gmail.com  
 
Source of Monetary or Material Support  
Indian Psychiatric Society Plot 43, Sector 55 Gurugram, Haryana, India, Pin: 122003 
 
Primary Sponsor  
Name  Indian Psychiatric Society 
Address  Indian Psychiatric Society Plot 43, Sector 55 Gurugram, Haryana, India, Pin: 122003 
Type of Sponsor  Other [Scientific Organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr B C Malathesh  AIIMS Bibinagar  Room no 13, Department of Psychiatry first floor, OPD block Bibinagar, Dist.Yadadari Bhuvanagiri, Telangana-508126
Nalgonda
TELANGANA 		 918806406530

bc.malathesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS BBN- Insitutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 only standard treatment will be given.  
Comparator Agent  Treatment as usual for the control arm  The patients in the control arm will receive the standard treatment of alcohol withdrawal syndrome as per standard treatment protocols 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age 18-50 yrs
more than 10 score (moderate severity) CIWA-Ar score Able to give consent for study
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.
 		 Assessments will be made everyday for 7 consecutive days.

Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7.
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="782"
Sample Size from India="782" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bc.malathesh@gmail.com].

  6. For how long will this data be available start date provided 19-08-2025 and end date provided 19-11-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Alcohol withdrawal syndrome is also characterized by severe disturbances in sleep because of reduced secretion of melatonin in the body. Exogenous administration of Melatonin has not been adequately studied for treatment of alcohol withdrawal syndrome. In the current study we want to study the efficacy of melatonin (5mg) fin controlling alcohol withdrawal syndrome. The study will be conducted as an open label trial with two arms. Participants suffering from alcohol withdrawal syndrome, meeting inclusion criteria, admitted to AIIMS Bibinagar, AIIMS Deogarh & AIIMS Guwahati Psychiatry ward, will be randomised (using block randomisation method) to either control or intervention arm. Participants in control arm will receive treatment as usual as per the standard treatment protocols for the treatment of Alcohol withdrawal syndrome. Those in Intervention arm will receive melatonin (5mg) tablet every night for 7 days along with the treatment as usual. Participants in both the arms will be assessed for various sleep indices using a wrist worn sleep tracking device for 7 days. Participants in both arms will also be assessed for severity of withdrawal symptoms every day for 7 days. The data will be compared between the two groups interms of sleep indices, withdrawal scores, benzothiazines dosage received etc. 
Close