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CTRI Number  CTRI/2023/11/059450 [Registered on: 02/11/2023] Trial Registered Prospectively
Last Modified On: 14/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   How alcohol affects the liver and put you on risk of heart diseases? 
Scientific Title of Study   Cardiovascular risk in alcoholic and non alcoholic fatty live patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhinav Manish 
Designation  Assistant Professor 
Affiliation  Gautam Buddha Chikitsa Mahavidyalaya Jhajra Dehradun 
Address  2/118 Dept of Biochemistry 2nd floor admin building Gautam Buddha Chikitsa Mahavidyalaya NH-74 chakrata road Dehradun Uttarakhand

Dehradun
UTTARANCHAL
248007
India 
Phone  7455074233  
Fax    
Email  abhinav5manish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhinav Manish 
Designation  Assistant Professor 
Affiliation  Gautam Buddha Chikitsa Mahavidyalaya Jhajra Dehradun 
Address  2/118 Dept of Biochemistry 2nd floor admin building Gautam Buddha Chikitsa Mahavidyalaya NH-74 chakrata road Dehradun Uttarakhand

Dehradun
UTTARANCHAL
248007
India 
Phone  7455074233  
Fax    
Email  abhinav5manish@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhinav Manish 
Designation  Assistant Professor 
Affiliation  Gautam Buddha Chikitsa Mahavidyalaya Jhajra Dehradun 
Address  2/118 Dept of Biochemistry 2nd floor admin building Gautam Buddha Chikitsa Mahavidyalaya NH-74 chakrata road Dehradun Uttarakhand

Dehradun
UTTARANCHAL
248007
India 
Phone  7455074233  
Fax    
Email  abhinav5manish@gmail.com  
 
Source of Monetary or Material Support  
Dr Abhinav Manish Assistant Professor 2/118 Dept of Biochemistry 2nd floor Admin block Gautam Buddha Chikitsa Mahavidyalaya Jhajra NH-74 chakrata road Dehradun 248007 
 
Primary Sponsor  
Name  GBCM and DrKKBM Subharti Medical College 
Address  GBCM and DrKKBM Subharti Hospital NH74 jhajra chakrata road Dehradun 248007 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
GBCM Medical College  GBCM and DrKKBM Subharti Hospital NH74 jhajra chakrata road Dehradun 248007 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhinav Manish  GBCM  Dept of Biochemistry and GBCM DrKKBM Subharti Hospital
Dehradun
UTTARANCHAL 
7455074233

abhinav5manish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionsl Ethics Committee For Biomedical And Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Ultrasonographically confirmed patients with fatty liver 
 
ExclusionCriteria 
Details  Age less than 20 and more than 80 Diabetes Mellitus, Hypertension, Confirmed Endocrinopathies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
primary outcome is risk associated with cardiovascular system in alcoholic hepatitis   at baseline.  
 
Secondary Outcome  
Outcome  TimePoints 
Estimation of biochemical parameters in ALD & NALD patients.
Comparison of Lipid profile among ALD & NALD.
Comparison of Liver Profile among ALD & NALD.
Evaluation of Cardiovascular risk associated with alcoholic & non alcoholic patients. 
at baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/11/2023 
Date of Study Completion (India) 01/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
https://doi.org/10.36478/makrjms.2024.6.342.347 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
A prospective cross-sectional study will be planned to be conducted in the dept of Biochemistry of GBCM and Dr. KKBM Subharti Medical Hospital Jhajra Dehradun the study shall be comparing 120 USG confirmed cases of fatty liver attending the OPD as well as IPD of Medicine and Surgey of Hospiatl from july to december 2023.
All over the world alcoholic and non-alcoholioc fatty liver disease are one of the commonest etiology of chronic liver disease. Increased alcohol consumption has held it to increase morbidity, hospital admission, and mortality of alcoholic liver disease. Non-alcoholic fatty liver disease spectrum includes fatty liver, Steatiohepatitis and Cirrhosis. Similarly, ALD spectrum includes simple steatosis, alcoholic hepatitis , combination of alcoholic hepatitis and cirrhosis. alcohol consumption is prevalent all over the world, in Men 40 to 80% of ethanol leads to fatty liver, and 160 gm/day from 10 to 20 years results in hepatitis or liver cirrhosis. only 15% of alcoholics develop alcoholic liver disease. Autonomic dysfunction has been observed in patients with CLD. In most of these studies, autonomic dysfunction has been attributed to an alcoholic-mediated neuropathy, but other liver related mechanisms are conceivable as chronic alcoholism with liver damage has a higher frequency of neuropathy than without it. The Cardiovascular risk is highly evident in alcoholic fatty liver disorder. So we are planning to conduct the study at GBCM and DrKKBM Subharti Hospital.
 
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