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CTRI Number  CTRI/2024/11/076466 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 28/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Other (Specify) [antilipidemic]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Polyherbal Ayurvedic formulation (Obegar G150) in management of Obesity. 
Scientific Title of Study   A Pilot Clinical Study to evaluate Efficacy and Safety of Polyherbal formulation (Obegar G150) in management of 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 Santosh Kamble 
Designation  Associate Professor 
Affiliation  Dr D.Y.Patil College Of Ayurved and Research Centre,Pimpri,Pune-18.Dr.D.Y.Patil Vidyapeeth,Pune  
Address  Dr D.Y.Patil College Of Ayurved,Hospital and Research Centre,Pimpri,Pune-18. Department of Swasthavritta,OPD No.07. Dr.D.Y.Patil Vidyapeeth,Pune(Deemed to be University)

Pune
MAHARASHTRA
411018
India 
Phone  8010874446  
Fax    
Email  santosh.kamble@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Kamble 
Designation  Associate Professor 
Affiliation  Dr D.Y.Patil College Of Ayurved and Research Centre,Pimpri,Pune-18.Dr.D.Y.Patil Vidyapeeth,Pune  
Address  Dr D.Y.Patil College Of Ayurved,Hospital and Research Centre,Pimpri,Pune-18. Department of Swasthavritta,OPD No.07. Dr.D.Y.Patil Vidyapeeth,Pune(Deemed to be University)

Pune
MAHARASHTRA
411018
India 
Phone  8010874446  
Fax    
Email  santosh.kamble@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Kamble 
Designation  Associate Professor 
Affiliation  Dr D.Y.Patil College Of Ayurved and Research Centre,Pimpri,Pune-18.Dr.D.Y.Patil Vidyapeeth,Pune  
Address  Dr D.Y.Patil College Of Ayurved,Hospital and Research Centre,Pimpri,Pune-18. Department of Swasthavritta,OPD No.07. Dr.D.Y.Patil Vidyapeeth,Pune(Deemed to be University)

Pune
MAHARASHTRA
411018
India 
Phone  8010874446  
Fax    
Email  santosh.kamble@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil Vidyapeeth,Pune(Deemed to be University) 
 
Primary Sponsor  
Name  Sudhatatva Pharmacy  
Address  Dr. D.Y.Patil College of Ayurved and Research Center, Pimpri, 411018.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Santosh Kamble  Dr D.Y.Patil College Of Ayurved, Hospital and Research Centre,Pimpri,Pune-18.   Dr D.Y.Patil College Of Ayurved,Hospital and Research Centre,Pimpri,Pune-18. Department of Swasthavritta,OPD No.07
Pune
MAHARASHTRA 		 8010874446

santosh.kamble@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.D.Y.Patil College of Ayurved and Research Centre,Pimpri,Pune  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 ArmDrugOther than Classical(1) Medicine Name: Tab. Obegar G -150, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: OBEGAR G 150 TAB IS PREPARED FROM SCHEDULE FIRST AYURVEDA HERBS FOR ITS CLINICAL TRIAL ON OBESITY.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Obese Patients above 18 years to 60 Years.
2.Both Male and female sex included in trial.
3.Patients with Body mass index(BMI)more than 25kg/m2
4.Patients having signs and symptoms of Sthaulya(Obesity) as Per ayurveda and modern texts  
 
ExclusionCriteria 
Details  1)Patient having any systemic disorders which require long term drug treatment
2)Patients with Body Mass Index (BMI) more than 40kg/m2
3)Patients with complaint of Cardiovascular diseases
4)Pregnant women, ascites, portal hypertension
5)Unable to provide written informed consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in BMI and Blood lipid levels.  TIME POINTS-14TH-28TH DAY FOLLOW UP WILL BE TAAKEN FOR Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 th days. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Visceral fat% and other clinical sign symptoms of Obesity  TIME POINTS-14TH-28TH DAY FOLLOW UP WILL BE TAKEN FOR Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 th 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)   25/11/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  On request data will be made available through mail .

  6. For how long will this data be available start date provided 01-11-2024 and end date provided 01-11-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This is a prospective, open label, Pilot-clinical trial for 28 days. Total 30 Obese  patients will participate in single group through eligibility criteria. Outpatients of age 18-60 years, of either sex having Body Mass Index (BMI) >25kg/m2 Will be included in this study after written informed consent.30 patients will receive  tablet Obegar G150 (polyherbal formulation) Orally, 500 mg, Twice a day, daily after meal, for 28 days. 

Subjective Parameters and clinical assessment through body fat monitor will be assessed at baseline, 14th, and 28th day. Laboratory Parameters (Lipid Profile) will be done at Screening/baseline and after completion of the study period i.e.28 thdays.

All the relevant data regarding the clinical study will be collected and

presented in tabular form. The observations and results obtained from clinical

study will be analyzed statistically to evaluate the significance of the curative

properties of therapies.


conclusion will be drawn as per the results drawn from the study.

 
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