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CTRI Number  CTRI/2025/06/089415 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 26/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To find out the safety and effectiveness of Chlordiazepoxide in Alcohol withdrawl syndrome patients 
Scientific Title of Study   Prospective, multi-center, open-label study to evaluate the effectiveness and safety of chlordiazepoxide in mild to moderate Alcohol withdrawal syndrome patients using CIWA-Ar scale in Deaddiction centers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AMD/P/25/001 Version 1.0, Dated 07.05.2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amar Shinde 
Designation  Principal Investigator 
Affiliation  Jagruti Rehabilitation Centre 
Address  Room number 1 ground floor Jagruti Rehabilitation Centre Siddhi Vinayak Plot no 37 Taloja Phase 1 Rd Petali Taloja Panchanand Sector 5 Taloja Navi Mumbai Maharashtra

Mumbai
MAHARASHTRA
410208
India 
Phone  9822207717  
Fax    
Email  dramar79@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amar Shinde 
Designation  Principal Investigator 
Affiliation  Jagruti Rehabilitation Centre 
Address  Room no 1 ground floor Jagruti Rehabilitation Centre Siddhi Vinayak Plot no 37 Taloja Phase 1 Rd Petali Taloja Panchanand Sector 5 Taloja Navi Mumbai Maharashtra

Mumbai
MAHARASHTRA
410208
India 
Phone  9822207717  
Fax    
Email  dramar79@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jawahar Nidamboor 
Designation  Assistant Vice President 
Affiliation  Alpha MD Pvt Ltd 
Address  1st Floor 315 Balgovind Wadi opp. Prabhadevi Mandir Prabhadevi Mumbai Maharashtra

Mumbai
MAHARASHTRA
400025
India 
Phone  9769796370  
Fax    
Email  jawahar.nidmboor@alphamd.com  
 
Source of Monetary or Material Support  
Abbott India Ltd 
 
Primary Sponsor
Modification(s)  
Name  Abbott Healthcare Pvt Ltd 
Address  Abbott Healthcare Pvt Ltd Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club Bandra (E) Mumbai 400 051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D Vijayanand  Jagruti Rehabilitation Center  Jagruti Rehabilitation Centre 944 17th Main road Thirumoolar colony Anna Nagar Chennai 600038
Chennai
TAMIL NADU 		 9176091896

vijayanandsanatana1711981@gmail.com 
Dr Aanchal Miglani  Jagruti Rehabilitation Center  Jagruti Rehabilitation Centre B-17 Sector 30 Noida Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 9910005996

aanchalmiglani2703@gmail.com 
Dr Amar Shinde  Jagruti Rehabilitation Center  Jagruti Rehabilitation Centre Siddhi Vinayak Plot no 37 Taloja Phase 1 Rd Petali Taloja Panchanand Sector 5 Taloja Navi Mumbai Maharashtra 410208
Mumbai
MAHARASHTRA 		 9822207717

dramar79@gmail.com 
Dr Mahendra Mane  Jagruti Rehabilitation Center  Jagruti Rehabilitation Centre Zhagade Wasti Near Loni Toll Naka Farm Solapur Pune Hwy Manjri Hadapsar Pune Maharashtra 412307 India
Pune
MAHARASHTRA 		 9423279025

dr.mahendramane@gmail.com 
Dr Suman Rajpara  Jagruti Rehabilitation Center  Jagruti Rehabilitation Centre B24 Greenwood Garden City Sardar Patel Ring Road Vibhag 1 OGNAJ Ahmedabad Gujarat 380060
Ahmadabad
GUJARAT 		 7874217483

suman.patel4995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
ACEAS Independent Ethics Committee  Approved 
Central Independent Ethics Committee-CIEC  Approved 
Ethicare Ethics Committee  Approved 
Saarthak Ethical Research Independent Ethics Committee   Approved 
Universal Independent 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  Chlordiazepoxide tablets  Chlordiazepoxide daily for 12 days Oral tablets 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Males and females of more than 18 to less than 60 years
Patients should be admitted in deaddiction centers after 6 hours of last alcohol use with Day 0
CIWA Ar score
Patients meet criteria for mild to moderate AWS (DSM V) by the investigator
Patient admitted in the deaddiction centers should be willing to give consent to participate into the trial
Liver Parameters- AST or ALT less than 2 times ULN 
 
ExclusionCriteria 
Details  Dependent on any substance other than alcohol except nicotine
History of severe alcohol withdrawal complications (alcohol withdrawal seizures, epilepsy or
delirium tremens)
History of hepatic encephalopathy less than 1 year & other liver disease less than 6 months
Received medications that may alter AWS presentation such as Antipsychotics other
benzodiazepines (except rescue doses))
Known contraindications to chlordiazepoxide
Pregnant or nursing females
Patients with the inability or unwillingness to comply with the study protocol 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage reduction in AWS symptoms based on daily CIWA Ar
score from baseline to day 12 		 Day 0 baseline to day 12 
 
Secondary Outcome  
Outcome  TimePoints 
LFT parameter before and at end of the study period
Number of days required for reduction of agitation and tremors
Number of minimum symptoms days
Incidence of rebound symptoms (smooth withdrawal)
Dropout rate
Percentage of Delirium Tremens patients
Outcome in mild liver dysfunction patients 		 Day 0 baseline to day 12 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   10/07/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Alcohol abuse is the biggest problem here: India has an estimated 160 million users of alcohol. This adds up to 14.6% of the Indian population. About 5.2% of the Indian population needs treatment for alcohol dependence. Alcohol withdrawal syndrome (AWS) occurs when patients stop drinking or significantly decrease their alcohol intake after long-term dependence. The clinical presentation varies from mild to severe, and the onset of symptoms typically occurs a few hours after the last alcohol intake. Benzodiazepines have the largest and the best evidence base in the treatment of alcohol withdrawal. Long-acting BZD are preferred and are considered as the gold standard. Chlordiazepoxide is a long-acting benzodiazepine, that is used in patients with AWS. The starting dose of Chlordiazepoxide in AWS patients usually ranges from 100-150mg/day, which is subsequently down-titrated over a period of 10-15 days and gradually withdrawn. Currently, there are limited Indian studies on safety and effectiveness of chlordiazepoxide in AWS patients.
 
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