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

Not Applicable

Completed

• Registration Number: CTRI/2019/05/019107
• Lead Sponsor: ADSO Naturals Holdings BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-10-05
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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 <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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢ The comparison of changes in biomarker from baseline to end of Visit <br/ ><br>â?¢ Changes in VO2 max values from baseline to end of visit <br/ ><br>Timepoint: Baseline Visit (Day 1) and End of Visit (Day 90)

Secondary Outcome Measures

Name	Time	Method
â?¢ Subject quality of Health Analysis SF-36: In Base line visits and all other visits <br/ ><br>â?¢ Monitor Adverse Event and Safety Profile Analysis <br/ ><br>Timepoint: Baseline Visit (Day 1) and End of Visit (Day 90)