| CTRI Number |
CTRI/2024/12/078092 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association of oja dushti in alcoholic fatty liver disease |
|
Scientific Title of Study
|
An observational study of association of oja dushti in alcoholic fatty liver disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Namdeo Gangawane |
| Designation |
Pg Scholar |
| Affiliation |
Tilak Ayurveda Mahavidyalaya,Pune |
| Address |
Rognidan Department,Tilak Ayurveda Mahavidyalaya ,Rasta Peth,Pune,Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9156103835 |
| Fax |
|
| Email |
gangawanes710@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant Professor M.D , Ph.D Rognidan |
| Affiliation |
Tilak Ayurveda Mahavidyalaya , Pune |
| Address |
Rognidan evum Vikriti Vigyan Department, Tilak Ayurveda Mahavidyalaya , Rasta Peth , Pune , Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr@81gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Ranade |
| Designation |
Assistant Professor M.D , Ph.D Rognidan |
| Affiliation |
Tilak Ayurveda Mahavidyalaya , Pune |
| Address |
Rognidan evum Vikriti Vigyan Department, Tilak Ayurveda Mahavidyalaya , Rasta Peth , Pune , Maharashtra 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9423876727 |
| Fax |
|
| Email |
ashmr81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya , Rasta Peth , Pune-411011 , Maharashtra , India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya , Rasta Peth , Pune , Maharashtra 411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Shubham Gangawane |
Tilak Ayurveda Mahavidyalaya , Seth Tarachand Ramnath Charitable Ayurved Hospital , Pune |
Rognidan Department , Tilak Ayurveda Mahavidyalaya , Rasta Peth , Pune , Seth Tarachand Ramnath Charitable Ayurved Hospital, Rasta Peth , Pune
Pune
MAHARASHTRA |
9156103835
gangawanes710@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAY AND SETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K700||Alcoholic fatty liver. Ayurveda Condition: YAKRUJJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Irrespective of gender, religion,marital status ,economical status ,race.
2)participants known diagnosed for alcoholic fatty liver disease with or without symptoms like anorexia , abdominal pain ,fatigue, weight loss, nausea , vomiting.
3) Participants known diagnosed for alcoholic fatty liver disease with ulatrasonography of abdomen .
4) Participants known diagnosed for alcoholic fatty liver disease with typical laboratorical finding might be increase in bilirubin level and elevated ratio of AST and ALT in LFT .
5) Participants taking alcohol minimum 35-180 ml/day for atleast 6 months. |
|
| ExclusionCriteria |
| Details |
1) Participants of Non-alcoholic fatty liver disease .
2) Participants of Alcoholic fatty liver disease associated with pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of oja dushti in alcoholic fatty liver disease |
18 Months and 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of oja dushti & chronicity in alcohol consumption |
18 Months & 0 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/12/2024 |
| 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="6"
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
|
Alcohol related liver diseases contribute various range of health hazardous through out the world. Alcoholism and related disease has roots deep down in ancient days. Ayurveda also has mentioned various diseases and pathological conditions related to alcoholism. The interesting fact about the alcohol in Ayurveda is it has properties unfavourable to Oja . If it is so then this study aims to identify such relation of alcoholic liver diseases and oja dushti can be observed in patients.
To study the association of oja dushti in alcoholic fatty liver disease . To study the association of oja dushti and chronicity in alcohol consumption.
|