| CTRI Number |
CTRI/2025/06/088757 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical study to compare how well two herbal powders (Yava-Amalaki and Musta) work in managing obesity in adults. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Compare The Efficacy Of Oral Administration Of Yawa Amalaki Choorna With Musta Choorna In Sthaulya Among Adults |
| 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 Saurabh sanjay chindage |
| Designation |
PG scholar |
| Affiliation |
Tilak ayurved mahavidyalaya pune |
| Address |
OPD no.5 , department of kayachikitsa,Tilak ayurved mahavidyalaya,rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9588640091 |
| Fax |
|
| Email |
saurabhchindage1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAbhaychandra inamdar |
| Designation |
Associate professor |
| Affiliation |
Tilak ayurved mahavidyalaya pune |
| Address |
OPD no.5, department of kayachikitsa,Tilak ayurved mahavidyalaya,rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7722073303 |
| Fax |
|
| Email |
drasinamdar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Saurabh sanjay chindage |
| Designation |
PG scholar |
| Affiliation |
saurabhchindage1998@gmail.com |
| Address |
OPD no.5, Department of kayachikitsa,Tilak ayurved mahavidyalaya,rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9588640091 |
| Fax |
|
| Email |
saurabhchindage1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune,411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Rasta Peth,Pune,411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saurabh sanjay chindage |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune |
OPD no.5 department of kayachikitsa
Pune
MAHARASHTRA |
09588640091
saurabhchindage1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yawa Amalaki , Reference: Charak Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta, Reference: Charak Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Participients having signs and symptoms of Stholya
2.Participients of Age Group: 18years to 40years.
3.Participients of any sex, religion and socio-economic status.
4.Untreated cases
5.Participients with BMI Between 25kg/m2 to 39 kg/m2. |
|
| ExclusionCriteria |
| Details |
1.Genetic syndromes associated with sthoulya.
2.Complicated participient having target organ damage.
3.K/C/O-Malignancy, poorly controlled DM, HTN.
4.Participient having other acute complicated systemic disease or diseases which require long term drug treatment.
5.Symptomatic participient with clinical evidence of heart failure.
6.Participient who currently under medications like weight loss agents, centrally acting appetite suppressants.
7.Needs Prior surgical therapy for obesity.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out which herbal powder — Yava-Amalaki Choorna or Musta Choorna — works better in helping overweight adults lose weight and improve their health when taken by mouth. |
Follow up after every 15th day for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see how each herbal powder — Yava-Amalaki Choorna & Musta Choorna — affects other health factors related to obesity, such as digestion, energy levels, blood sugar, cholesterol, & overall well-being in overweight adults. |
Follow up after every 15th day for 2 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="1"
Months="6"
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
|
The clinical trial titled “A Randomized Controlled Clinical Trial to Compare the Efficacy of Oral Administration of Yawa Amalaki Choorna with Musta Choorna in Sthaulya (Obesity) in Adults” focuses on evaluating two Ayurvedic formulations for managing obesity—a rising global health concern. Sthaulya, as described in Ayurvedic texts, results from imbalances in lifestyle and diet, leading to excessive accumulation of fat and muscle tissue. Modern treatments for obesity often fall short in terms of efficacy and sustainability, whereas Ayurveda offers holistic approaches including herbal formulations, dietary management, and physical practices.
This study aims to assess and compare the effectiveness of Yava-Amalaki choorna and Musta choorna—two readily available, cost-effective, and natural remedies—in treating obesity. The rationale lies in providing safer and more efficient alternatives through Ayurvedic medicine. It also offers an opportunity for researchers to apply clinical methodologies and contribute to the evolving body of Ayurvedic evidence. |