| CTRI Number |
CTRI/2025/09/095130 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate efficacy of Trimada Churna in the management of Sthaulya with special reference to obesity |
|
Scientific Title of Study
|
A Randomize Comparative Clinical Trial To Evaluate Efficacy Of Trimada Churna And Tryushan Churna In The Management Of Sthaulya(Obesity) |
| 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 Dhanashree Prakash Rathod |
| Designation |
Pg Scholar |
| Affiliation |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital |
| Address |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital,Kaychikitsa Department, Hospital Building, th Floor, Nipani, Bhalgaon,Chatrapati Sambhaji Nagar,Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8999453721 |
| Fax |
|
| Email |
docdhanu@16gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Subhashrao Solanke |
| Designation |
Professor |
| Affiliation |
|
| Address |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital,Kaychikitsa Department, Hospital Building, 4th Floor, Nipani, Bhalgaon,Chatrapati Sambhaji Nagar,Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7447801802 |
| Fax |
|
| Email |
meerasolanke20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanashree Prakash Rathod |
| Designation |
Pg Scholar |
| Affiliation |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital |
| Address |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital,Kaychikitsa Department, Hospital Building, th Floor, Nipani, Bhalgaon,Chatrapati Sambhaji Nagar,Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8999453721 |
| Fax |
|
| Email |
docdhanu@16gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital Nipani-Bhalgaon
Near Videocon comp ltd Beed Highway Chhatrapati Sambhajinagar (Aurangabad) Maharashtra
431005 |
|
|
Primary Sponsor
|
| Name |
Shivas Trusts, Yashwantrao Chavhan Ayurvedic Medical College And Hospital |
| Address |
Nipani-Bhalgaon Near Videocon comp ltd Beed Highway Chhatrapati
Sambhajinagar (Aurangabad) Maharashtra 431005 |
| Type of Sponsor |
Private 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 Dhanashree Prakash Rathod |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
Nipani-Bhalgaon Near
Videocon comp ltd Beed
Highway Chhatrapati
Sambhajinagar
(Aurangabad)
Maharashtra 431005
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA |
8999453721
docdhanu@16gmail.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:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trimada Churana, Reference: Bhavprakash Nigantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryushan Churna, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients suffering from symptoms of Sthaulya described in Ayurvedic Samhita’s [41] such as Angachalatva (movements of body), Alpavyavay (decreased libido), Kshudrashwasa (dyspnoea), Dourgandhya (bad smell of body), Swedadhikya (profused sweating), Atipipasa (excessive thirst), Atikshuda (excessive hunger) will be selected for trial.
•
Patients will be selected on the basis of B.M.I. (Body Mass Index) above 30-35.
•
The patients within the age group 16 to 70 years will be selected irrespective of gender. |
|
| ExclusionCriteria |
| Details |
Patient with major systemic disorder or other illness clinical evidence of heart failure, serious hepatic disorder.
Pregnant and lactating women.
Drug induced obesity, Autoimmune disorder, Harmonal disorder HIV, DM, HTN
Obesity due to certain secondary causes. |
|
|
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 evaluate the efficacy of Trimada Churana in the management of
Sthaulya roga with special referance to Obesity |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Trimad Churana and Tryushan Churna in the
management of Sthaulya with special referance to Obesity |
follow-up on 15th,
30th,45th, 60th day |
|
|
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)
|
29/09/2025 |
| 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 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
|
Ayurveda, the science of life, emphasizes prevention over cure. According to classical texts, Sthaulya (obesity) is considered a disorder of improper nourishment where Meda Dhatu (fat tissue) is excessively nourished while other tissues become weak. It is linked with defects such as reduced lifespan, weakness, excessive hunger, thirst, sweating, and unpleasant body odor. In modern medicine, obesity is recognized as a chronic disease and a major risk factor for non-communicable diseases like diabetes, heart disease, stroke, and cancer.
Obesity prevalence in Maharashtra is around 23.8%, and modern treatments (dieting, physiotherapy, anti-lipidemic drugs) often show limited results. Ayurveda offers an alternative with herbal formulations and lifestyle management. Trimada Churna (Musta, Chitraka, Vidanga) is one such formulation with Sthoulyahara (anti-obesity) properties, traditionally used with honey. The study aims to compare the efficacy of Trimada Churna and Tryushan Churna in managing Sthaulya, providing a holistic Ayurvedic approach to obesity management. |