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CTRI Number  CTRI/2024/04/066475 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of assessment of environmental factors like diet, lifestyle in relation with fatty liver disease patients  
Scientific Title of Study   Assessing Environmental Factors as one of the major developments for fatty liver disease – A questionnaire-based study in Wardha  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nisha Barole 
Designation  Post graduation Clinical Research 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Gastronology, Acharaya Vinobha Bhave Rural Hospital, DMIHER,Sawangi,Wardha - 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9307682122  
Fax    
Email  barole.nisha09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijendra Kirnake 
Designation  Professor & HOD 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Gastronology, Acharya Vinoba Bhave Rural Hospital, DMIHER, Sawangi, Wardha; Maharashtra 442001

Wardha
MAHARASHTRA
442001
India 
Phone  7768901370  
Fax    
Email  drvijendrakirnake@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nisha Barole 
Designation  Post graduation Clinical Research 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Dept. of Gastronolgy, Acharaya Vinobha Bhave Rural Hospital, DMIHER,Sawangi Wardha 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9307682122  
Fax    
Email  barole.nisha09@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha - 442001, Maharashtra, India 
 
Primary Sponsor  
Name  Nisha Barole 
Address  Dept. of Clinical Research Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha - 442001, Maharashtra, India 
Type of Sponsor  Private medical college 
 
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 
Nisha Barole  Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha   Dept. of Gastronology, DMIHER, Sawangi, Wardha - 442001
Wardha
MAHARASHTRA 
9307682122

barole.nisha09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E807||Disorder of bilirubin metabolism,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults aged 18-65 years.
No pre-existing liver conditions.
Consent to genetic testing and regular follow-ups.
 
 
ExclusionCriteria 
Details  Individuals with a history of significant alcohol consumption.
Known genetic conditions predisposing to liver disease.
Current use of medications influencing liver function.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this research study is to look into the association among environmental factors: Lifestyle, emotional well being and diet along with the prevalence of fatty liver disease to include individuals residing in Wardha.  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcome  Not applicable 
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
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)   01/06/2024 
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="1"
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 - NO
Brief Summary  

Abstract:

The people with fatty liver disease (FLD), which is becoming a bigger health problem around the world, are more likely to get more difficult because of things in their environment. The objective of this Wardha questionnaire-based thesis is to find out how environmental factors impact FLD, since these may play a big part in how the disease starts. There are clear rules for the study about what to include and what not to include so that the data is correct and there is less bias. For the study, a group of people from Wardha that is similar to a number of social groups will be chosen. The study is meant to be useful and helpful in general, the sample will be chosen at random. A lot of information will be gathered from the questionnaires that the participants fill out about their living conditions, eating habits, level of physical activity, and exposures at work. This is done by using both standard tools and interviews carried out by experienced researchers to make sure that everything is reliable and correct. Their medical histories, body measurements, and biochemical markers will be recorded as well into so that researchers can find relates to throughout the number of FLDs and the level of bad they are. It is looked at how things like eating a lot of calories, not being active enough, having problems at work, and having toxins in the home can contribute to the rise of FLD. It’s possible to learn more about risk factors that are specific to a population by doing subgroup analyses based on age, gender, and income. The environment plays a big role in the development of FLD, and this study looks into the complicated link between them.

 
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