CTRI/2025/02/080585尚未招募Phase 3 4
A Prospective, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Efficacy, and Bioavailability of PS2 in Physical Performance.
Akay Natural Ingredients Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2月24日
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluate the effect of PS2 in Physical Performance
研究概览
简要总结
This is a double blind, parallel group, randomized clinical trial. Adult subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into one of the four treatment arms (1:1:1:1) to receive different doses of PS2 or placebo for 7 days. Baseline blood samples will be collected for the laboratory assessments and safety assessments (Visit 1) and will be dispensed a subject diary and IP and will be instructed to return for follow-up visits on Day 1 & Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.BMI between 18.5 and 29.9 kg/m² 2.Non-smokers and non-alcoholic participants 3.Engaged in moderate physical activity 4.Willing to maintain their habitual diet and exercise routine during the study period 5.Able to provide informed consent and comply with the study protocol.
排除标准
- •1.History of cardiovascular, metabolic, renal, or gastrointestinal disorders 2.Use of medications affecting nitric oxide metabolism 3.Recent use of nitrate-rich dietary supplements 4.Regular use of antibacterial mouthwash (as it affects nitrate metabolism) 5.Pregnancy or lactation 6.Allergic to PS2 or any supplement components.
结局指标
主要结局
Evaluate the effect of PS2 in Physical Performance
时间窗: Baseline and Day 7
次要结局
- Assess the bioavailability markers after the acute supplementation of PS2 in different doses(Day 1)
- Safety Parameters(Baseline and Day 7)
研究者
Dr Harshith C S
BGS Global Institute of Medical Sciences
研究点 (1)
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