| CTRI Number |
CTRI/2026/01/100074 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Medovaha Srotodushti in Type 2 Diabetes Mellitus: A Comparative Study of Patients With and Without Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Development and Validation of Medovaha Srotodushti Nidana Questionnaire and Analytical Cross-Sectional Study to Compare Degree and Pattern of Medovaha Srotodushti in Type 2 Diabetes Mellitus Patients With and Without Non-Alcoholic Fatty Liver Disease (NAFLD) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ganpat Kumar |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619667003 |
| Fax |
|
| Email |
ganpat9610chou@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surendra Kumar Sharma |
| Designation |
HOD Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414361874 |
| Fax |
|
| Email |
ssurendra452@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganpat Kumar |
| Designation |
MD Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619667003 |
| Fax |
|
| Email |
ganpat9610chou@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan, 302002, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar singh gate, Amer road, Jaipur, 302002 |
| Type of Sponsor |
Government 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 |
| Dr Ganpat Kumar |
National Institute of Ayurveda Hospital |
OPD 17 and OPD 06, Department of Roga Nidana Evum Vikriti Vigyana, National Institute of Ayurveda, Jorawar singh gate, Amer road
Jaipur
RAJASTHAN |
8619667003
ganpat9610chou@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECNIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Group1
Patients of either sex aged between 18 to 70 years, Patients diagnosed as Prameha (Type 2 Diabetes Mellitus) with fasting plasma glucose level 126 mg per dl or higher and or HbA1C level more than 6.4 percentage, Individuals with non-alcoholic fatty liver disease
Group 2
Patients of either sex aged between 18 to 70 years, Patients diagnosed as Prameha (Type 2 Diabetes Mellitus) with fasting plasma glucose level 126 mg per dl or higher and or HbA1C more than 6.4 percentage. |
|
| ExclusionCriteria |
| Details |
group 2
Patients diagnosed with Type 1 Diabetes Mellitus (IDDM)
Patients with malignancies or any other serious illness.
Pregnant and lactating women.
Alcohol consumption more than 20 g per day (women) and more than 30 g per day (men).
Patients with alcoholic fatty liver disease
Group 2
Patients diagnosed with Type 1 Diabetes Mellitus (IDDM). Patients with malignancies or any other serious illness. Pregnant and lactating women. Patients diagnosed with diabetes insipidus
Patients with alcoholic and non alcoholic fatty liver disease |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the effectiveness of the developed tool in evaluating Medovaha Srotodushti in Type 2 Diabetes Mellitus (T2DM) with or without Non-Alcoholic Fatty Liver Disease (NAFLD). |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the effectiveness of the developed tool in evaluating Medovaha Srotodushti in Type 2 Diabetes Mellitus (T2DM) with or without Non-Alcoholic Fatty Liver Disease (NAFLD). |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
14/09/2026 |
| 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="2"
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
|
This dissertation is a two-phase methodological and analytical cross-sectional study designed to integrate Ayurvedic pathophysiology with modern metabolic assessment in Type 2 Diabetes Mellitus (T2DM). In Phase 1, a standardized Medovaha Srotodushti Nidana Questionnaire is systematically developed and validated through extensive review of classical Ayurvedic texts, expert consultations, pilot testing, and statistical evaluation of reliability and validity (including internal consistency, test–retest reliability, and content and construct validity). The tool operationalizes classical Nidana such as Avyayama (physical inactivity), Divaswapna (day sleep), Medyanam Atibhakshana (excessive intake of fatty foods) and related lifestyle-behavioral factors into measurable domains. In Phase 2, the validated questionnaire is applied in an analytical cross-sectional study involving 140 T2DM patients, equally divided into those with and without Non-Alcoholic Fatty Liver Disease (NAFLD), to compare the degree and pattern of Medovaha Srotodushti. The study further evaluates correlations between questionnaire scores and biomedical parameters including BMI, lipid profile, liver enzymes (SGOT/SGPT), fasting blood glucose, and HbA1c. By generating comparative and correlative evidence, this research aims to bridge a critical gap in Ayurvedic research by providing a scientifically validated assessment tool and enhancing understanding of Medovaha Srotodushti in the context of diabetes and NAFLD, thereby supporting integrative diagnosis, risk stratification, and preventive strategies. |