A clinical study to evaluate the efficacy and safety of investigational product Everhearty(TM)in management of cardiac health in healthy volunteers
- Conditions
- For Management of cardiac health
- Registration Number
- CTRI/2019/05/019107
- Lead Sponsor
- ADSO Naturals Holdings BV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
-
- 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.
- 1.Subjects with uncontrolled type 2 diabetics, blood pressure and symptomatic hypotension.
- History of heart attack, stroke and coronary/cerebrovascular events.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
- Subjects with previous history of surgery 6.
- Pregnant and lactating women.
- Any clear indication or a contraindication to the use of any of the study medications.
- Participation in any other clinical study using investigational medicinal product or device within 3 months prior to baseline visit.
- Inability to take or consume investigational product.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • The comparison of changes in biomarker from baseline to end of Visit Baseline Visit (Day 1) and End of Visit (Day 90) • Changes in VO2 max values from baseline to end of visit Baseline Visit (Day 1) and End of Visit (Day 90)
- Secondary Outcome Measures
Name Time Method • Subject quality of Health Analysis SF-36: In Base line visits and all other visits • Monitor Adverse Event and Safety Profile Analysis
Trial Locations
- Locations (1)
Dr. B.R Ambedkar Medical College
🇮🇳Bangalore, KARNATAKA, India
Dr. B.R Ambedkar Medical College🇮🇳Bangalore, KARNATAKA, IndiaDr Shivakumar B RPrincipal investigator9900329850brdrshivakumar@gmail.com