| 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
|
|
|
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
|
|
|
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. |