CTRI/2025/01/079658尚未招募3 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lycopene 20% powder (a standardized Solanum lycopersicum extract) in Healthy Adult Subjects.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in serum levels of LDL.
研究概览
简要总结
The purpose of this study is to evaluate the beneficial effects of Lycopene powder (a standardized Solanum lycopersicum extract) on safety and efficacy in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged 40-70 years.
- •Participants at risk for cardiovascular disease, as indicated by one or more of the following: • Elevated LDL cholesterol levels (≥ 120 mg/dL to ≤160 mg/dL).
- •Participants must be on a stable medication regimen for at least 3 months prior to the study, if applicable.
- •Participants with BMI 18.5-24.9kg/m
- •Individuals must be able and willing to provide informed consent.
- •Individuals must be able to comply with the study protocol and procedures.
排除标准
- •Subjects with a history of hypersensitivity to lycopene.
- •Subjects with a BMI ≥25 kg/m2 3) Subjects with a family history of hypercholesterolemia 4) Current use of any supplement, herbal products or drugs for the management of hyperlipidaemia.
- •Presence of significant liver or renal disease.
- •History of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months.
- •Active malignancy or history of cancer within the last 5 years.
- •Pregnant or lactating women, and women of childbearing potential not using adequate contraceptive measures or found positive for a urine pregnancy test.
- •Participation in another clinical trial within 30 days prior to study entry.
结局指标
主要结局
Mean change in serum levels of LDL.
时间窗: Baseline, Day 42, Day 84
次要结局
- 1) Change in serum levels of total cholesterol, HDL cholesterol and triglycerides(Baseline, Day 42, Day 84)
- 2) Change in the vital signs .(Baseline, Day 42, Day 84)
- 3) Change in the safety parameters including Complete Blood Count (CBC), blood Chemistry, thyroid profile, liver function tests (ALT, AST, and bilirubin) and renal function tests (creatinine and BUN)(Baseline, Day 84)
- 4) Assessment of tolerability, incidence and severity of adverse events.(Day 42 and Day 84)
研究者
Dr K Sunil Naik
Government Medical College & Government General Hospital (Old RIMSGGH)
研究点 (1)
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