CTRI/2020/07/026907已完成2/3 期
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to evaluate Efficacy and Safety of KaraHeart on the Lipid Profile of mild to moderate hyperlipidemia in subjects who are at risk for cardiovascular disease.
GreenChem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月30日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from the baseline to the end of the treatment period in the levels of total cholesterol,High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL)and Triglyceride (TGL)
研究概览
简要总结
This proposed study is a randomized, double-blind, placebo-controlled trial, investigating the efficacy and safety of KaraHeart versus placebo in improving the symptoms of hypercholesterolemia in otherwise healthy population aged between 20 to 60 years. The observed outcomes through primary and secondary endpoints results will be analysed to check the safety and efficacy of this synergistic herbal formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult men and women subjects between the age groups of 20–60 years with the confirmed case of mild to moderate hyperlipidemia.
- •2.As per ATP III guidelines; baseline LDL ranging >100 mg/dL, TC >200 mg/dL, TGL ranging 150-199 mg/dL, VLDL-Cholesterol >40 mg/dL, HDL-cholesterol: Men- <40mg/dL, and women -<50mg/dL 3.Subjects having all or at least any one of the diagnostic criteria mentioned above will be selected for the study.
- •4.Subjects with low BMI but abnormal lipid profile.
- •5.Subjects who are able to understand the risks/benefits of the protocol and are willing to give written informed consent.
排除标准
- •1.Subjects on concurrent lipid-lowering medications like statins, or fibrates, or dietary supplements within 30 days prior to screening.
- •2.Subjects suffering from Hyperlipidemia due to Consumption of drugs such as glucocorticoids.
- •3.Subjects with chronic diseases requiring continuous use of vasoactive,diuretics or lipid-lowering drugs.
- •5.Subjects having history of any major illness of cardiovascular diseases eg.Angina pectoris, myocardial infarction etc.
- •6.Subjects having a history of thyroid disorder (TSH- levels of <0.4 or >10µg/dL), renal disorder, cholelithiasis or polycystic ovary syndrome (PCOS).
- •7.Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose 140-199 mg/dl.
- •8.Subjects having abnormal liver or kidney function test (ALT or AST) 2 times the upper limit of normal; elevated creatinine (male 125 μmol/L, female 110 μmol/L).
结局指标
主要结局
Change from the baseline to the end of the treatment period in the levels of total cholesterol,High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL)and Triglyceride (TGL)
时间窗: Day 0, Day 30, Day 60, Day 90, Day 120
次要结局
- Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein B(Day 0 and Day 120)
- Change from the baseline to the end of the treatment period in the level of Lipid peroxidation(Day 0 and Day 120)
- Change from the baseline to the end of the treatment period in the level of C-Reactive Protein(Day 0 and Day120)
- Change from the baseline to the end of the treatment period in the level of Total Cholesterol Vs HDL Cholesterol(Day 0, Day 30, Day 60, Day 90, Day 120)
- Change from the baseline to the end of the treatment period in the level of Serum Apolipoprotein A1(Day 0 and Day 120)
- Change from the baseline to the end of the treatment period in the level of HbA1C(Day 0 and Day 120)
- Change from the baseline to the end of the treatment period in the level of Ankle Brachial reflex(Day 0 and Day 120)
研究者
研究点 (1)
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