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 Limited1 个研究点分布在 1 个国家目标入组 56 人开始时间: 2022年10月2日最近更新: 2022年1月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Olene Life Sciences Private Limited
入组人数: 56
试验地点: 1
主要终点: Change from Baseline to End of the study in

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Rapidly growing prevalence of cardiovascular disease is a major threat for the developed as well as developing world warranting urgent need of intervention. Complementary and alternative medicines are gaining popularity among general population because of their safety profile and easy administration. Garlic, in particular, is considered to be one of the best disease-preventive foods because of its potent and widespread effects. This study is to find out the role of garlic in cardiovascular disease prevention.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 30.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•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 â‰¥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.

排除标准

•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.