CTRI/2025/01/079615尚未招募4 期
An Open labelled study to assess the safety and tolerability of VISPO (standardized saw palmetto oil) in healthy adult human subjects.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean change in safety parameters including Complete Blood Count (CBC), Blood biochemistry, Lipid profile, Liver Function Tests (LFT) and Renal Function Tests (RFT)
研究概览
简要总结
The study is designed to assess the safety and tolerability of VISPO in three visits and assessments includes the evaluation of adverse events and laboratory tests to monitor CBC, blood biochemistry, lipid profile, LFT and RFT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male volunteers aged 40-70 years.
- •Body Mass Index (BMI) between 18.5 and 24.9 kg/m².
- •Stable medication regimen for at least 3 months prior to the study (if applicable).
- •Agrees to comply with the study protocol and procedures.
- •Agrees to not participate in any other clinical trials during the course of this trial.
- •Willing to participate in the study and provide informed consent.
排除标准
- •History of hypersensitivity to fish oil or astaxanthin.
- •Current use of other investigational drugs.
- •Use of omega-3 supplements or astaxanthin supplements within 4 weeks prior to the study.
- •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 following adequate contraceptive measures or women who were found positive for 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 safety parameters including Complete Blood Count (CBC), Blood biochemistry, Lipid profile, Liver Function Tests (LFT) and Renal Function Tests (RFT)
时间窗: Day 1, Day 14, Day 28
次要结局
- 1) Change in vital signs parameters(Day 1, Day 14, Day 28)
- 2) Assessment of tolerability, incidence and severity of adverse events(Day 1, Day 14, Day 28)
研究者
Dr K Vidyasagar
Government Medical College & Government General Hospital (Old RIMSGGH)
研究点 (1)
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