FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070724 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of mustadi ghan vati with diet and exercise in sthaulya with special reference to Obesity in children 12 to 16 years  
Scientific Title of Study   Randomized controlled clinical trial to study the add on effect of Mustadi Ghana Vati along with lifestyle (diet and exercise) modification in Sthaulya with special reference to Obesity in children of age 12 to 16 years. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amruta Surwase 
Designation  PG student 
Affiliation  LRP medical college  
Address  Pediatric department opd 1 st floor LRP medical college Uran

Sangli
MAHARASHTRA
415409
India 
Phone  9022979067  
Fax    
Email  amrutasurwase02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Patil  
Designation  Asso. Professor  
Affiliation  LRP medical college  
Address  1 st floor ,OPD no 2 of Kaumarbhritya -Balrog Department LRP medical college Uran islampur 415409

Sangli
MAHARASHTRA
415409
India 
Phone  9022979067  
Fax    
Email  sandeep.patil76.sp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amruta Surwase 
Designation  PG students 
Affiliation  LRP medical college  
Address  1 St floor ,OPD no 2 of Kaumarbhritya -Balrog Department LRP medical college Uran islampur 415409

Sangli
MAHARASHTRA
415409
India 
Phone  9022979067  
Fax    
Email  amrutasurwase02@gmail.com  
 
Source of Monetary or Material Support  
LRP medical college Uran Islampur, Maharashtra 415409 
 
Primary Sponsor  
Name  Amruta Surwase 
Address  LRP medical college Uran Islampur, Maharashtra 415409 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amruta Surwase  Loknete Rajarambapu Patil Ayurvedic medical college Hospital   1 st floor ,OPD no 2 of Kaumarbhritya -Balrog Department LRP medical college Uran islampur 415409
Sangli
MAHARASHTRA 		 9022979067

amrutasurwase02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Report of Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: STHULARUSHKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Diet and exercise Daily 15 minof exercise for 3 months
2Intervention ArmDrugClassical(1) Medicine Name: Mustadi ghanavati, Reference: Charak Sutrasthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -no
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Patients between 12-16 years of age of either sex.
2. Patients presenting with sign and symptoms of sthaulya. (Kshudrashwas, Kshudhadhikya, Trushna, Moha, Daurbalya, Alpaprana etc.) 
 
ExclusionCriteria 
Details  1. Patients with known case of major systemic disorders or other illness which interfere with the present study.
2. Patients with known case of Endocrinal disorders like hypothyroidism, Cushing syndrome and genetic syndromes.
3. Children with known case of drug induced obesity.
Withdrawal Criteria – Patients will be withdrawn from the study group
if-
1. Children not following instruction more than 5 days will be withdrawn
from the study.
2. Any adverse drug reaction occurs.
3. The children not willing to continue the trial.
4. Rescue drug will be given if any major Systemic disorder occurs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce the over weight with the drug mustadi ghanavati in Sthaulya   3 months  
 
Secondary Outcome  
Outcome  TimePoints 
1. To reduce the over weight in 3 months
2. To know the characteristics of mustadi ghanvati.
3. To assess improvement by assessment criteria of 3 months
 		 12 months  
 
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)   19/07/2024 
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   This is randomised controlled clinical trail to study in which ayurvedic formulation will be provided to 30 patients showing signs and symptoms of sthaulya and other group of 30 patients will be on diet and exercise . The age group taken for study trial will be between 12 Years to 16 Years and the total duration of study will be 1 year . Final conclusion will be drawn on the basis of statistical method. 
Close