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
|
|
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. |