| CTRI Number |
CTRI/2025/07/090075 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To analyze the effect of an ayurvedic herb in obese individuals. |
|
Scientific Title of Study
|
To assess the efficacy of musta churna on stahulya and its effect on associated inflammatory markers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAGHELA AJAYBHAI MANUBHAI |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital |
| Address |
Department of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India
Central DELHI 110005 India |
| Phone |
8849181598 |
| Fax |
|
| Email |
ajayvaghela7511@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sujata Rajan |
| Designation |
HOD (Associate Professor) |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India
Central DELHI 110005 India |
| Phone |
9354925026 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sujata Rajan |
| Designation |
HOD (Associate Professor) |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Kriya Sharira, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India
Central DELHI 110005 India |
| Phone |
9354925026 |
| Fax |
|
| Email |
sujataa.rajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, karol bagh, New Delhi - 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, karol bagh, New Delhi - 110005 |
| 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 AJAYBHAI |
A & U TIBBIA COLLEGE AND HOSPITAL |
PG DEPARTMENT OF KRIYA SHARIRA, A & U TIBBIA COLLEGE AND HOSPITAL KAROL BAGH NEW DELHI 110005 Central DELHI |
8849181598
ajayvaghela7511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Tibbia college |
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: musta churna, Reference: API, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -USHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. obese individuals from both the genders in the age group of 18 - 40 years.
2. BMI greater than or equal to 30 kg/m2 and less than or equal to 34.5 Kg/m2. |
|
| ExclusionCriteria |
| Details |
1. Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader willi syndrome).
2. Patients with poorly controlled Hypertension (greater than 160 / 100 mm Hg)
3. Patients on prolonged (greater than 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
4. H/o hypersensitivity to any of the trial drugs or their ingredients.
5. Choose the patients who were not enrolled in any study within six (06) months of initial visit.
6. DM, Dyslipidemia, Metabolic Disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Obesity based on the Questionnaire |
post completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of effect on selective biomarkers (inflammatory markers) : IL6, TNF alpha and CRP |
90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/01/2026 |
| 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="1" 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
|
Excess body fat is the characteristics of obesity, a chronic health risk that is becoming more widespread. It appears gradually and frequently lasts a lifetime. In the United States, obesity is second only to smoking as a preventable cause of mortality. Obesity was formerly thought to be linked to wealthy lifestyles in western nations. Nonetheless, obesity is a rapidly expanding issue in emerging nations and is currently linked to heightened health hazards. Numerous research conducted in India have demonstrated a link between the rising risk of metabolic disorders such type 2 diabetes mellitus, hypertension, and dyslipidaemia with changes in dietary patterns, levels of physical activity, and affluent lifestyles. Obesity affects people of all ages and genders today. Currently, one-third of people on the planet are obese or overweight. Consequently, the treatment is centred on current global issues. According to a review of the literature, there are many different Ayurvedic anti-obesity formulations in the market, however there aren’t many that balance all the tridoshas and reduce obesity. In order to optimise the formulation for the intended therapeutic impact, minimising the drawbacks of earlier literature in this study. Reducing body weight by limiting the absorption of nutrients is one of the treatment approaches. |