| CTRI Number |
CTRI/2025/09/095022 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
EXPLORING THE ROLE OF FAT METABOLISM IN PEOPLE SUFFERING FROM DIABETES |
|
Scientific Title of Study
|
ASSESSMENT OF MEDOVAHA SROTODUSHTI IN MADHUMEHA. |
| 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 Shruti Bahuguna |
| Designation |
P.G Scholar |
| Affiliation |
Rishikul Campus, Haridwar,Uttrakhand Ayurved University |
| Address |
OPD & IPD no. 21, P.G Department of Rog Nidan Evum Vikriti Vigyan, Rishikul campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077522396 |
| Fax |
|
| Email |
shruti.bahuguna1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Rishikul Campus, Haridwar , Uttrakhand Ayurved University |
| Address |
OPD & IPD No. 21, P.G Department of Rog Nidan Evum Vikriti Vigyan, Rishikul campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415284453 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Bahuguna |
| Designation |
P.G Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttrakhand Ayurved University |
| Address |
OPD & IPD No. 21,P.G Department of Rog Nidan Evum Vikriti Vigyan, Rishikul campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077522396 |
| Fax |
|
| Email |
shruti.bahuguna1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus Haridwar, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus ,UAU 249401 |
| Address |
Rishikul Campus ,UAU Haridwar Pin Code-249401 , India |
| 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 Shruti Bahuguna |
Rishikul Ayurvedic College And Hospital |
P.G Department of Rog Nidan Evum Vikriti Vigyan , Rishikul Campus , Haridwar
Hardwar
UTTARANCHAL |
8077522396
shruti.bahuguna1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Uttarakhand Ayurved University , Rishikul campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 18-60 years of either sex , willing to participate in the study , having classical symptoms of Madhumeha and fulfilling diagnostic criteria for Diabetes Mellitus will be included in this study.
Blood Sugar Level for Inclusion -
Fasting blood sugar (FBS)more than 126 mg/dl up to 250 mg/dl
Postprandial blood sugar (PPBS) more 200 mg/dl up to 400mg/dl
|
|
| ExclusionCriteria |
| Details |
Patients less than 18 years and more than 60 years.
Known cases of HIV, Tuberculosis, Malignant Disorders, Chronic Kidney diseases, Chronic liver diseases, and Malnourished.
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help in assessing the role of Medovaha Srotodushti in Madhumeha in relation to change in the blood glucose level and lipid level. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between Medovaha Srotodushti
and Madhumeha severity |
1 month |
|
|
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)
|
28/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/09/2025 |
| 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
|
Diabetes mellitus, a leading lifestyle disorder, continues to rise despite modern treatments, demanding holistic approaches. In Ayurveda, Madhumeha is described under Prameha, where ancient Acharyas emphasize the role of Medovaha Srotodushti in its pathogenesis. This study aims to evaluate the extent of correlation between Medovaha Srotas and Madhumeha as mentioned by classical texts, by assessing classical features along with Fasting Blood Sugar, Post Prandial Blood Sugar, Urine, and lipid profile investigations, thereby supporting integrative diabetes management. |