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CTRI Number  CTRI/2017/04/008295 [Registered on: 05/04/2017] Trial Registered Retrospectively
Last Modified On: 30/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to evaluate the efficacy and safety of CGA-7 on the Risk Factors of Obesity. 
Scientific Title of Study   A Prospective, Randomized, Double blind, Parallel group, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of CGA-7 on the Risk Factors of Obesity 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
VH/HP/03 Version 1.0 18/06/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran M Goud 
Designation  Principal Investigator 
Affiliation  Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre 
Address  Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Medical Centre No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage Bangalore
No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
Bangalore
KARNATAKA
560104
India 
Phone  9845109556  
Fax    
Email  skamcbangalore@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Supreeth 
Designation  Co Investigator 
Affiliation  Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre 
Address  No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
Bangalore
KARNATAKA
560104
India 
Phone  9742918461  
Fax    
Email  supreethmj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Supreeth 
Designation  Co Investigator 
Affiliation  Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre 
Address  No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
Bangalore
KARNATAKA
560104
India 
Phone  9742918461  
Fax    
Email  supreethmj@gmail.com  
 
Source of Monetary or Material Support  
Vidya Herbs Pvt Ltd 
 
Primary Sponsor  
Name  Vidya Herbs Pvt Ltd 
Address  #30, 33rd Main, 16th cross J.P. Nagar 6th Phase Bangalore- 560078 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Kiran M Goud  Sri Kalabyraveswara Swamy Ayurvedic Medical College, Hospital and Research Centre  No.10, Pipeline Road, RPC Layout, Vijayanagar 2nd Stage, Bangalore - 560104
Bangalore
KARNATAKA 		 9845109556

skamcbangalore@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, SKAMC&RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Male and female overweight or obese subjects with BMI of 25-30 in the age group of 18-60 years ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CGA-7  Coffea Arabica 
Comparator Agent  Placebo  Maltodextrin 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to give written informed consent.

2. Patient is willing and able to comply with all trial requirements

3. Overweight or obese; BMI between 25-30 
 
ExclusionCriteria 
Details  • Subjects with BMI >30

• Cigarette smoker, History of heart, liver and kidney disease, hypertension, pregnancy, lactating, Type 1 diabetes and weight loss medication.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment

2.Muscle mass-fat mass ratio, body fat (%)
 		 1.Reduction in body weight and BMI at week 4, 8 and 12 of treatment

2.Muscle mass-fat mass ratio, body fat (%) at visit 1 (Day 1) and final visit (12th week)
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in lipid profile (Triglycerides, cholesterol, HDL and LDL)

2.Blood pressure

3.Changes in anthropometric measurements – Waist and hip circumference; Waist-hip ratio

4.Quality of life of subjects before and after treatment

5.Incidence and rate of adverse events
 		 12 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 3 
Date of First Enrollment (India)   04/01/2017 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Mentioned 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The trial is a prospective, randomized, double blind, parallel group, placebo controlled study to estimate the efficacy and safety of CGA-7 on the risk factors of obesity. The CGA-7 molecule was tested on rats that were fed with high fat diet to estimate its potential of anti-obesity property. After successful preclinical study, CGA-7 complex is now being investigated for its body fat loss effect in overweight and obese individuals.


 
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