| CTRI Number |
CTRI/2025/11/096964 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs,Jarul and Musta in patients with Obesity |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Jarul (Lagerstroemia speciosa Linn.Pers.) Churna verses Musta (Cyperus rotundus Linn.) Churna in the Management of Sthaulya (Obesity) A Randomized Controlled Trial |
| 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 Snehal Balki |
| Designation |
BAMS Post Graduate |
| Affiliation |
Mahatma gandhi ayurved college,hospital and research centre |
| Address |
Dept of Dravyaguna MAhatma gandhi ayurved college hospital and research centre Salod wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8862015710 |
| Fax |
|
| Email |
snehalbalki08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaimala Jadhav |
| Designation |
Professor and HOD Dept of Dravyaguna |
| Affiliation |
Mahatma gandhi ayurved college,hospital and research centre |
| Address |
Department of Dravyaguna mahatma gandhi ayurved college hospital and research centre Salod wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922190843 |
| Fax |
|
| Email |
jaimala.jadhav@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Balki |
| Designation |
BAMS Post Graduate |
| Affiliation |
Mahatma gandhi ayurved college,hospital and research centre |
| Address |
Department of Dravyaguna Mahatma gandhi ayurved college hospital and research centre Salod wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8862015710 |
| Fax |
|
| Email |
snehalbalki08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma gandhi ayurved college hospital and research centre salod wardha, 442001 maharastra |
|
|
Primary Sponsor
|
| Name |
MGACHRC |
| Address |
MGACHRC salod wardha 442001 |
| 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 Snehal Balki |
mgachrc |
Mahatma gandhi ayurved college hospital and research centre,salod,wardha 442001
Wardha
MAHARASHTRA |
8862015710
snehalbalki08@gmail.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 |
| Healthy Human Volunteers |
Obesed volunteers with bmi ranging from 25 to 40 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: jarul, Reference: Commentary of Pandey & Chunekar on Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: musta, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Healthy obesed volunteers with bmi ranging from 25 to 40kg per meter square |
|
| ExclusionCriteria |
| Details |
1 Endocrine and systemic disorders 2 Drug included obesity 3 Anti lipidemic medication 4 Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in anthropometric parameters like body weight bmi circumferences |
90 days |
|
|
Secondary Outcome
|
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/01/2026 |
| 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="0"
Months="3"
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
|
Obesity Sthaulya is a lifestyle disorder described in Ayurveda as excessive Meda deposition,strongly linked with metabolic complications.Conventional treatments are often costly and associated with side effects, prompting the need for safe alternatives. Lagerstroemia speciosa Jarul and Cyperus rotundus Nagarmotha are traditional Medohara dravyas with potential anti obesity activity.This randomized, double-blind, controlled trial will include 62 patients BMI 25 to 40 kg per meter square treated for 12 weeks. Efficacy will be assessed through BMI, waist hip ratio, anthropometric measures, and lipid profile. The study aims to validate and compare their effectiveness, providing evidence based, affordable, and holistic Ayurvedic options for obesity management. |