| CTRI Number |
CTRI/2024/02/063272 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
TO ASSES MEDOVAHA STROTO DUSHTI LAKSHANANI IN NON ALCOHOLIC FATTY LIVER DISEASE |
|
Scientific Title of Study
|
A CASE CONTROL STUDY TO ASSESS MEDOVAHA STROTO DUSHTI LAKSHANANI IN NON 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 |
Vd Narendra Gajanan Mohale |
| Designation |
PG Scholar |
| Affiliation |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya VishwashantiDham Kesnand Road Wagholi,Pune.Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya VishwashantiDham Kesnand Road Wagholi,Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9637366628 |
| Fax |
|
| Email |
ngmali1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Arun Kulkarni |
| Designation |
Professor and HOD of Rog Nidan Evum Vikruti Vigyan. |
| Affiliation |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya VishwashantiDham Kesnand Road Wagholi Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9422164367 |
| Fax |
|
| Email |
archana.arukulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Arun Kulkarni |
| Designation |
Professor and HOD of Rog Nidan Evum Vikruti Vigyan. |
| Affiliation |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya VishwashantiDham Kesnand Road Wagholi Pune.
Pune
MAHARASHTRA
412207
India |
| Phone |
9422164367 |
| Fax |
|
| Email |
archana.arukulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Vishwashanti Dham Kesnand Road Wagholi Pune. |
|
|
Primary Sponsor
|
| Name |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya . |
| Address |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Vishwashanti Dham Kesnand Road Wagholi Pune. |
| 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 |
| Vd Narendra Gajanan Mohale |
Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya |
OPD and IPD patients of all departments of Bharatiya Sanskriti Darshan Trust Ayurved Mahavidyalaya Vishwashanti Dham Kesnand Road Wagholi Pune
Pune
MAHARASHTRA |
9637366628
ngmali1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: Non-Alcoholic Fatty Liver disease , (2) ICD-10 Condition:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) Group A (Case) - • Patient Irrespective of gender in age group of 18-60 years. • Newly or already diagnosed patient of non- alcoholic fatty liver in USG shows fatty liver diseases. B) Group B (Case)- • Age and Irrespective of Gender matched control group. |
|
| ExclusionCriteria |
| Details |
Below 18 years and above 60 years, Pregnant women, Uncooperative patient, Alcoholic fatty liver. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and document the Association between MedovahaStrotodushtilakshanani in Non-Alcoholic Fatty Liver Disease. |
Assessment will be done on day 0 and day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe & document the Association between Non-Alcoholic Fatty Liver Disease & Lipid profile |
Assessment will be done on day 0 and day 1 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/03/2024 |
| 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
|
The present case control study is to asses the relationship of Non-alcoholic fatty liver diseases with concept of medovahastroto dushti lakshan. Total 100 volunteer will be taken divided 50 in case group consist of newly or already diagnosed non-alcoholic fatty liver disease participants and 50 of control group in that assessment of medovahastroto dushti lakshan will be done with specially designed case record form and on next day lipid profile test will be done. The relation between two would be aimed to adopt the early diagnosis of disease from Ayurveda perspective to avoide further complications.Early-stage detection would help in giving better idea regarding preventive and curative aspect such as changing lifestyle and dietery pattern |