A Randomized, Double-Blind, Parallel Group Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors

Olene Life Sciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•1 Male or female subjects between 30 to 65 years of age
•2 Ability to understand the risks benefits of the protocol
•3 Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy
•4 Serum triglycerides > 115mg/dL and less than < 199 mg/dL
•5 If Former smoker (previously smoked >=10 cigarettes/day for at least 1 year, cessation for at least 6 months
•6 Willing to give written informed consent and willing to comply with trial protocol

•Pregnant or breast feeding women
•Serum glucose levels higher than 126 mg/dL
•Use of cholesterol lowering medication or supplements
•Use of blood pressure lowering medication
•Subjects having abnormal liver or kidney function tests ALT or AST more than 2 times the upper limit of normal elevated Creatinine, males more than 125 Î¼mol per L females more than 110 Î¼mol per L renal insufficiency thyroid or other endocrine disease
•Any other condition that, in the opinion of the investigator would adversely affect the subject s ability to complete the study or its measures
•Hypersensitivity to any of the ingredient used in the study supplements
•Alcohol consumption exceeding the definition of moderate drinking 2 drinks per day for men or 1 drink per day for women
•Subjects participated in any investigational study medication within thirty days prior to screening

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