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CTRI Number  CTRI/2019/05/019107 [Registered on: 14/05/2019] Trial Registered Prospectively
Last Modified On: 30/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate the efficacy and safety of investigational product Everhearty(TM)in management of cardiac health in healthy volunteers 
Scientific Title of Study   A Randomized, Double Blinded, Placebo Controlled Study to evaluate the efficacy and safety of Investigational product Everhearty(R) in management of cardiac health in healthy volunteers 
Trial Acronym  Everhearty 
Secondary IDs if Any  
Secondary ID  Identifier 
BIAG-CSP-018   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivakumar B R 
Designation  Consultant  
Affiliation  Dr. B.R Ambedkar Medical College 
Address  Dr. B.R Ambedkar Medical College Kadugondanahalli, Bangalore – 560045, Karnataka, India
Dr. B.R Ambedkar Medical College Kadugondanahalli, Bangalore – 560045, Karnataka, India
Bangalore
KARNATAKA
560045
India 
Phone  9900329850  
Fax    
Email  brdrshivakumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Dayananda 
Designation  General Manager 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  Director 
Affiliation  BioAgile Therapeutics Pvt Ltd 
Address  2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage, Bangalore - 560094
Bangalore
KARNATAKA
560094
India 
Phone  08043754520  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Sponsored trial 
 
Primary Sponsor  
Name  ADSO Naturals Holdings BV  
Address  Zuthpensweg 55 7418 AH Deventer, The Netherlands 
Type of Sponsor  Other [Nutraceutical Product Manufacturing Company] 
 
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 Shivakumar B R  Dr. B.R Ambedkar Medical College   Dr. B.R Ambedkar Medical College Kadugondanahalli, Bangalore – 560045, Karnataka, India
Bangalore
KARNATAKA 		 9900329850

brdrshivakumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Dr. B. R. Ambedhar Medical College & Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For Management of cardiac health  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Everhearty Capsules  One 500 mg capsule to be taken after dinner for 12 weeks 
Comparator Agent  Starch from Corn  One 500 mg capsule to be taken after dinner for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Both gender with age 18 - 65 yrs.
2. Body mass index (BMI) between 18 and 40 kg/m2
3. Healthy volunteers who have two or more lipid values (TC >200 mg/dl, TG > 150 mg/dL, HDL <50 mg/dL and LDL > 100 mg/dL)
4. Normal 12 lead ECG
5. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
6. Subjects who have given voluntary, written, informed consent to participate in the study.

 
 
ExclusionCriteria 
Details  1.Subjects with uncontrolled type 2 diabetics, blood pressure and symptomatic hypotension.
2. History of heart attack, stroke and coronary/cerebrovascular events.
3. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
4. History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
5. Subjects with previous history of surgery
6. Pregnant and lactating women.
7. Any clear indication or a contraindication to the use of any of the study medications.
8. Participation in any other clinical study using investigational medicinal product or device within 3 months prior to baseline visit.
9. Inability to take or consume investigational product.
10. Allergies to one of the component substances in the trial
11. Treatment with anti-inflammatory/analgesic/antioxidant drugs in the previous month
12. History of substance misuse and alcoholism.
 
 
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 
• The comparison of changes in biomarker from baseline to end of Visit
• Changes in VO2 max values from baseline to end of visit
 		 Baseline Visit (Day 1) and End of Visit (Day 90) 
 
Secondary Outcome  
Outcome  TimePoints 
• Subject quality of Health Analysis SF-36: In Base line visits and all other visits
• Monitor Adverse Event and Safety Profile Analysis
 		 Baseline Visit (Day 1) and End of Visit (Day 90) 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/05/2019 
Date of Study Completion (India) 05/10/2019 
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   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Worldwide, the burdens of chronic diseases like cardiovascular diseases, cancers, diabetes and obesity are rapidly increasing. Cardio Vascular Disease (CVD) is a group of disorders associated with heart and blood vessels. The major type of CVD includes hypertension (high blood pressure), coronary heart disease (heart attack), cerebrovascular disease (stroke), peripheral vascular disease, heart failure, rheumatic heart disease, congenital heart disease and cardiomyopathies. Heart attacks and strokes are usually acute events and mainly caused by a blockage that prevents blood from flowing to the heart or brain. The most common reason for these fatal diseases is a build-up of fatty deposits on the inner walls of the blood vessels that supply the heart or brain. Strokes can also be caused by bleeding from a blood vessel in the brain or from blood clots. The cause of heart attacks and strokes are usually because of the presence of a combination of risk factors, such as tobacco use, unhealthy diet and obesity, physical inactivity and harmful use of alcohol, hypertension, diabetes and hyperlipidemia.
An inactive lifestyle leads to increased blood cholesterol levels and the accumulation of visceral fat; this is accompanied by an innate and adaptive immunological response at cellular and tissue levels leading to a persistent low-grade vascular inflammation, which is a key regulatory mechanism in the pathogenesis of atherosclerosis. The development of atherosclerosis leads to CAD, which becomes evident when it causes thrombosis, angina pectoris and/or myocardial infarction.
 
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