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临床试验/NCT05877677
NCT05877677已完成不适用

The Effects Assessment of the Polygonatum Kingianum Extract on Endurance Performance and Anti-fatigue

TCI Co., Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
50
试验地点
1
主要终点
The change of blood PDE5 gene expression

研究概览

简要总结

To assess the efficacy of polygonatum kingianum extract on endurance performance and anti-fatigue

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male aged 30-60 years old
  • Must read and sign the informed consent form
  • During the experiment, do not change the lifestyle and eating habits
  • Cooperate not to engage in high-intensity exercise 48 hours before each experiment

排除标准

  • Subject who is not willing to participate in this study.
  • People with serious diseases of heart, liver, kidney, endocrine and other organs (such as hypertension, diabetes, renal dysfunction and heart-related diseases) and mental patients
  • People who have undergone surgery within 6 months or have lower limb injuries
  • People who are allergic to Polygonatum kingianum extract
  • Participate in other clinical trials related to anti-fatigue within four weeks of the trial
  • Students who are currently taking courses taught by the principal investigator of this trial.

结局指标

主要结局

The change of blood PDE5 gene expression

时间窗: Day 0, day 14, day28

Fasting venous blood was sampled to measure the expression of PDE5 gene

The change of aerobic endurance

时间窗: Day 0, day 14, day28

3-min step test is used to assess aerobic endurance

The change of continuous attention performance

时间窗: Day 0, day 14, day28

Canon continuous attention software (Conners' Continuous Performance Test) is used to assess continuous attention performance

The change of concentration of testosterone in blood

时间窗: Day 0, day 14, day28

Fasting venous blood was sampled to measure concentrations of testosterone

次要结局

  • The change of blood nitric oxide (NO)(Day 0, day 14, day28)
  • The change of self-assessment fatigue condition(Day 0, day 14, day28)

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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