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CTRI Number  CTRI/2025/04/084820 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to check how alcohol drinking make changes in our genes and cause addiction 
Scientific Title of Study   Epigenetic Vulnerability to Alcohol Dependence: A Comparative Analysis of DNA Methylation and Gene Expression of Candidate Genes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohd Jahid Riyaz Ahmad Khan 
Designation  Research Scholar 
Affiliation  Kasturba Medical College Manipal Academy of Higher Education Manipal 
Address  Department of forensic medicine and toxicology Kasturba Medical College

Udupi
KARNATAKA
576104
India 
Phone  7208215581  
Fax    
Email  jahid.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mohd Jahid Riyaz Ahmad Khan 
Designation  Research Scholar 
Affiliation  Kasturba Medical College Manipal Academy of Higher Education Manipal 
Address  Department of forensic medicine and toxicology Kasturba Medical College

Udupi
KARNATAKA
576104
India 
Phone  7208215581  
Fax    
Email  jahid.kmcmpl2023@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vinod C Nayak 
Designation  Professor 
Affiliation  Kasturba Medical College Manipal Academy of Higher Education Manipal 
Address  Department of forensic medicine and toxicology Kasturba Medical College

Udupi
KARNATAKA
576104
India 
Phone  9845240393  
Fax    
Email  vinod.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Udupi Karnataka India 576104 
 
Primary Sponsor  
Name  Kasturba Hospital 
Address  Kasturba Hospital Manipal Udupi Karnataka India 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samir Kumar Praharaj  Kasturba Hospital  Department of Psychiatry third floor old OPD block
Udupi
KARNATAKA 		 8971026304

samir.kp@manipal.edu 
Dr Vinod C Nayak  Kasturba Medical College  Department of forensic medicine and toxicology second floor biochemistry building
Udupi
KARNATAKA 		 9845240393

vinod.nayak@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  For AD - Individual diagnosed with alcohol dependence by a qualified psychiatrist at
the Department of Psychiatry, Kasturba Medical College, MAHE Manipal
Capable of providing informed consent
Willing to participate in blood sampling
For Healthy - Individual with no history of alcohol dependence and other substance use.
Not having any first-degree relatives with a history of a major psychiatric
disorder
No psychiatric disorder screened using the Self Reporting Questionnaire SRQ
Age and sex-matched to the alcohol-dependent group
Capable of providing informed consent
Willing to participate in blood sampling 
 
ExclusionCriteria 
Details  For AD - Individuals currently diagnosed with major chronic or terminal diseases such as cardiovascular diseases and cancers major infectious conditions and severe mental disorders as well as lactating mothers and pregnant women Because these conditions can potentially influence DNA methylation patterns
Individual having substance dependence other than alcohol and tobacco
For Healthy - Individuals having first-degree relatives with a history of a major psychiatric
disorder
Individuals currently diagnosed with major chronic or terminal diseases such as cardiovascular diseases and cancers major infectious conditions and severe mental disorders as well as lactating mothers and pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Hypo or hypermethylation of the candidate gene assessed using methylation specific PCR and their impact on gene expression  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of dysregulated pathways & comorbidities associated with alcohol dependence  Baseline 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   30/04/2025 
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="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  NIL

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 30-04-2027 and end date provided 31-03-2033?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a Cross-Sectional Observational Case-Control Study aims to analyze and compare DNA methylation changes in the key genes associated with alcohol dependence between individuals with alcohol dependence and healthy controls and to identify dysregulated pathways associated with chronic alcohol consumption, thereby suggesting the development of potential biomarkers for treating and preventing alcohol dependence. Recruitment will begin from March 20 2025 after getting the CTRI reference number.  
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