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A clinical study to evaluate the efficacy and safety of investigational product Everhearty(TM)in management of cardiac health in healthy volunteers

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 - Everhearty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019107
Enrollment
24
Registered
2019-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Everhearty Capsules: One 500 mg capsule to be taken after dinner for 12 weeks Control Intervention1: Starch from Corn: One 500 mg capsule to be taken after dinner for 12 weeks.

Sponsors

ADSO Naturals Holdings BV
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
â?¢ The comparison of changes in biomarker from baseline to end of Visit â?¢ Changes in VO2 max values from baseline to end of visit Timepoint: Baseline Visit (Day 1) and End of Visit (Day 90)—

Secondary

MeasureTime frame
â?¢ Subject quality of Health Analysis SF-36: In Base line visits and all other visits â?¢ Monitor Adverse Event and Safety Profile Analysis Timepoint: Baseline Visit (Day 1) and End of Visit (Day 90)—

Countries

India

Contacts

Public ContactDivya C

BioAgile Therapeutics Pvt Ltd

pm@bioagiletherapeutics.com08043754520

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026