| CTRI Number |
CTRI/2025/08/092298 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess effect of dietary intervention of Yavadi soup in overweight individuals for lowering body weight, body fat |
|
Scientific Title of Study
|
An Exploratory Clinical study to assess the effect of Yavadi soup onMeda Dhatu Vruddhi in 18 to 50years overweight individuals |
| 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 Shweta Yogesh Kutte |
| Designation |
PhD Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre Nigdi Pune |
| Address |
Kriya Sharir Department
of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune
Kriya Sharir Department
of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9730473931 |
| Fax |
|
| Email |
shwetmore85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Kiran Chobhe |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurveda and Reaserch Centre Nigdi, Pune |
| Address |
Kriya Sharir Department of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune
Kriya Sharir Department of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune 411044 Maharashtra
Pune
MAHARASHTRA
411044
India |
| Phone |
9850716124 |
| Fax |
|
| Email |
chobheswati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Yogesh Kutte |
| Designation |
PhD Scholar |
| Affiliation |
PDEAs College of Ayurveda and Research Centre, Nigdi, Pune |
| Address |
Kriya Sharir Department of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune
Kriya Sharir Department of PDEAs college of Ayurved and Research Centre sector 25 pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9730473931 |
| Fax |
|
| Email |
shwetmore85@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Yogesh Kutte |
| Address |
Kriya Sharir Department of PDEAs college of Ayurved and Research Centre sector 25
pradhikaran Nigdi Pune 411044 Maharashtra India |
| Type of Sponsor |
Other [self] |
|
|
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 Shweta Yogesh Kutte |
College of Ayurved and Research Centre |
Kriya Sharir Department of PDEAs College of Ayurved and research Centre sector 25 Pradhikaran Nigdi Pune 411044
Pune
MAHARASHTRA |
9730473931
shwetmore85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of PDEAs College of Ayurved and Reserach Centre Nigdi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
high BMI individuals |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Yavadi Soup, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(g), Frequency: od, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -the mixture Yavadi will be cooked in water to make a soup out of it and it will be consumed at dinner time |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI -25.1kg/m2 to 29.9kg/m2
Non exercising individuals (individuals not doing brisk walking/jogging/gym/Yoga/swimming etc
since at least 1 month) |
|
| ExclusionCriteria |
| Details |
Pregnant and Lactating mothers
Individuals already following another diet plan or on weight loss therapy. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of Yavadi soup on
Meda Dhatu Vruddhi in 18 to 50 years overweight individuals. |
Effect of Yavadi soup on
Meda Dhatu Vruddhi in 18 to 50 years overweight individuals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -effect of Yavadi Soup on lipids & serum calcium |
-30 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="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
|
Overweight individuals eventually becomes obese if proper food is not consumed. Yavadi Soup mixture is a combination of Dravyas mentioned in Ayurveda. each content of this food formulation has medohara lipolytic properties as mentioned in Ayurvedic Compendia. In the era of fast pacing life availability of an easy to cook dietary formulation which can help to lose weight is the need of an hour. So a unique kind of soup mixture will be prepared based on principles of Ayurveda that will help in managing weight and body fat may prevent overweight individuals to land into obesity
|