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

ADSO Naturals Holdings BV0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•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.

•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.

发起方

ADSO Naturals Holdings BV