| CTRI Number |
CTRI/2025/08/092646 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Medovaha Srotasa imbalance symptoms in non-alcoholic fatty liver disease |
|
Scientific Title of Study
|
Assessment of Medovaha Srotasa Dushti Lakshana in non-alcoholic fatty liver disease (NAFLD): A Cross-Sectional Study |
| 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 ANIL POPAT PAREKAR |
| Designation |
Assistant Professor |
| Affiliation |
Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar. |
| Address |
Department of Rognidan Evam Vikriti Vigyan, Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar, navi Mumbai, Maharashtra.
Raigarh MAHARASHTRA 410210 India |
| Phone |
8087120973 |
| Fax |
|
| Email |
drparekarap@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR ANIL POPAT PAREKAR |
| Designation |
Assistant Professor |
| Affiliation |
Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar. |
| Address |
Department of Rognidan Evam Vikriti Vigyan, Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar, navi Mumbai, Maharashtra.
Raigarh MAHARASHTRA 410210 India |
| Phone |
8087120973 |
| Fax |
|
| Email |
drparekarap@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR ANIL POPAT PAREKAR |
| Designation |
Assistant Professor |
| Affiliation |
Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar. |
| Address |
Department of Rognidan Evam Vikriti Vigyan, Dr. G.D. Pol Foundations, YMT Ayurvedic Medical College & PG Institute, Kharghar, navi Mumbai, Maharashtra.
Raigarh MAHARASHTRA 410210 India |
| Phone |
8087120973 |
| Fax |
|
| Email |
drparekarap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G.D. Pol Foundations YMT Ayurvedic Medical College and PG Institute and Hospital, Sector 4, Institute Area, Kharghar, Navi Mumbai, Maharashtra, India. Pin code 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Anil Popat Parekar |
| Address |
Department of Rognidan Evam Vikriti Vigyana, YMT Ayurvedic Medical College and PG Institute, Sector 4, Institute Area, Kharghar, Navi Mumbai, Maharashtra, India. Pin code 410210 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
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 Anil Popat Parekar |
YMT Ayurvedic Medical College and PG Institute and Hospital |
Department of Rognidan Evam Vikriti Vigyan, Room No. 115, First Floor, Pathology Division, Ayurvedic College Building, Institute Area, Sector-4, Kharghar, Navi Mumbai, Maharashtra, India. 410210 Raigarh MAHARASHTRA |
8087120973
drparekarap@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: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals - 20 to 65 years of age with already diagnosed non-alcoholic fatty liver
disease irrespective of their gender, religion, caste, occupation, socio-economic status
etc., who can in their full consciousness, give clear consent for the project. |
|
| ExclusionCriteria |
| Details |
Known case of alcoholic fatty liver disease.
Patients with systemic diseases affecting multiple body systems and critically ill patients.
Pregnant and lactating women.
Individuals not willing to participate after information about the project or who do not
give a complete response to the questionnaire.
Individuals with Liver transplant. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of Medovaha Srotasa Dushti Lakshana in patients diagnosed with non-
alcoholic fatty liver disease.
Analyze the common Lakshana of Medovaha Srotasa Dushti and their severity in
relation to NAFLD grading. |
Outcome will be assessed/estimated at baseline on first visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="213" Sample Size from India="213"
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)
|
18/08/2025 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Roga Pariksha
(disease examination) is a core element of Ayurvedic diagnosis. However, in the
context of Yakrit Vikara (liver disorders), Ayurvedic literature offers
very limited information mainly discussing Yakritdalyudara, which is
insufficient for diagnosing complex modern liver diseases like Non-Alcoholic
Fatty Liver Disease (NAFLD). This research emphasizes the need to bridge
the knowledge gap between classical Ayurvedic texts and modern
hepatology by studying symptoms through the lens of Srotasa Dushti Lakshana
(channel vitiation) and Dhatu Dushti Lakshana (tissue vitiation). The
study aims to develop a reliable diagnostic framework (Lakshan Samuchaya)
for Yakrit Vikara Pariksha, focusing especially on Medovaha Srotasa Dushti,
which aligns with NAFLD, given that Medo Dushti (fat tissue disorder)
manifests as conditions like Sthoulya (obesity) and Prameha
(diabetes) both key risk factors for NAFLD.
Considering
the growing public health burden of liver diseases in India, and limited
Ayurvedic references to Yakrit Vikara, this work seeks to Compile and
reinterpret scattered Ayurvedic information on liver diseases, Align classical
concepts with modern diseases like NAFLD, Develop subjective and objective
tools for accurate Ayurvedic diagnosis, Promote standardization in
examination (same format and questions for all participants), Ultimately
re-establish a comprehensive Ayurvedic understanding of NAFLD while staying
true to classical principles. |