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CTRI Number  CTRI/2013/10/004096 [Registered on: 24/10/2013] Trial Registered Retrospectively
Last Modified On: 04/02/2019
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 efficacy and safety of CGA-7 complex capsules in reducing the bodyweight in obese patients 
Scientific Title of Study   A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of CGA-7 complex capsules in reducing the bodyweight in obese patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICBio/CR/VH/0628/29 Version 1.0 Dated 15-JUL-2013   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrANNAPOORNA SBhat BAMS MD MSCP DYT 
Designation  Family Physician 
Affiliation  Sampoorn Health Care 
Address  NO.2, 2nd Main, A.E.C.S. Layout, 3rd Stage, Sanjayanagar, Bangalore.

Bangalore
KARNATAKA
560094
India 
Phone  9886399730  
Fax    
Email  dr.sampoorna@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Harisha S 
Designation  Director-Operations 
Affiliation  ICBio Clinical research Pvt Ltd 
Address  ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Harisha S 
Designation  Director-Operations 
Affiliation  ICBio Clinical research Pvt Ltd 
Address  ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
Vidya herbs 
 
Primary Sponsor  
Name  VIdya Herbs 
Address  #30,33 Main JP nagar,6 Phase ,Bangalore-560078,India. 
Type of Sponsor  Other [Herbal Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagadeesh TV BAMS  Amruth Poly Clinic  Amruth Poly Clinic, Near Jana Priya Apartments, Allalasandra, Yelahanka, Bangalore – 64 Bangalore KARNATAKA 560064 India
Bangalore
KARNATAKA 		 9880134660

drjagadeeshtemkar@yahoo.com 
DrANNAPOORNA S Bhat  Sampoorn Health Care  NO.2, 2nd Main, A.E.C.S. Layout, 3rd Stage, Sanjayanagar, Bangalore-560094
Bangalore
KARNATAKA 		 9886399730

dr.sampoorna@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Clinical IEC Bangalore  Approved 
Clinical IEC Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CGA-7 complex Capsules  Three times a day before breakfast,lunch and dinner for 2 months taken orally 
Comparator Agent  Placebo  Three times a day before breakfast, lunch and dinner for 2 months taken orally 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Age between 18 and 60 years.
• Able to sign voluntarily informed consent.
• Obese subjects with Body mass index 30 to 40kg/m2
• Obese subjects with Waist circumference > 40 inches/102 cm in male, > 35 inches/88 cm in female
• Subjects must understand risks and benefits of the protocol
• In Lipid profile, Total cholesterol In Lipid profile, Total cholesterol ≥ 200, LDL level ≥ 150, HDL level ≤ 55 in both men & women, HbA1C ≤ 6%, Fasting blood glucose level< 100 and Fasting insulin level ≤ 7 µU/ml.
• Diet should be maintained.
• Willingness to participate in the exercise walking program
• Willingness to participate in 06 clinical visits (Screening, Day 1, Day 14, Day 28, Day 56 and Day 70).
• If female, should be negative in pregnancy test. Female of child bearing potential, should agree to follow an acceptable method of birth control for the duration of the study.
 
 
ExclusionCriteria 
Details  • Have a history of hypertension, Angina, stroke, thyroid diseases
• Any other clinically significant disorder
• Non-obese (BMI <30) & morbidity obese (>40).
• Presently using other weight loss medications, as well as stimulants, laxatives or diuretics taken solely for the purpose of weight loss
• Recent, unexplained weight loss or gain
• History of HIV positive patients
• History of hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis.
• History of motor weakness or peripheral sensory neuropathy
• Have orthopedic joint problems that would be barrier to physical activity such as walking.
• Are currently participating in any weight loss clinical trial.
• Women who are pregnant and nursing mothers
• People with major psychiatric illness
• Any contraindication to blood sampling 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
•Reduction in body weight and BMI   •At Screening ,day 14,day 28 and day 56 
 
Secondary Outcome  
Outcome  TimePoints 
•Changes in lipid profile
•Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction
•Quality of life of the subjects (SF-36)
•Hb1Ac concentration
•Incidence and rate of adverse events 		 At baseline and week 8 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/08/2013 
Date of Study Completion (India) 28/01/2014 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 A Prospective, Randomized, Double blind, Placebo controlled clinical trial to evaluate efficacy and safety of CGA-7 complex capsules in reducing the bodyweight in obese patients

Primary objectives:

·         To evaluate the safety and efficacy of CGA-7 complex treating obesity in obese patients

Secondary objectives:

To evaluate the safety and role of CGA-7 complex in improving the quality of life of the subjects

Primary outcomes

·         Reduction in body weight and BMI at Day 14, Day 28, Day 56 from Screening

Secondary outcomes

·         Changes in lipid profile (Screening and Day 56(EOT))

·         Changes in anthropometric measurements-Waist circumference and waist to hip ratio reduction (Day 1 and Day 56(EOT))

·         Quality of life of the subjects (SF-36) (Day 1 and Day 56(EOT))

·         Hb1Ac concentration (Screening and Day 56(EOT))

Incidence and rate of adverse events 

The drug which is been used in the study is a composition of an herbal product called Coffee bean extract. CGA-7 complex is a Coffee bean extract. CGA-7 is a 100% natural extract from Green coffee beans , which contains chlorogenic acids rich PolyPhenols
 
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