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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  
Name  Address 
NA  NA 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.
 
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