Effects of Lepidium Meyenii (Maca) Extract Supplementation on Male Sexual Funtion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Level of FSH
研究概览
简要总结
The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.
详细描述
All participants performed anthropometric measurements, blood collection and questionnaire survey at 0-week. A random, double-blind design will be used to assign 60 participants into the experimental group (n = 30) or placebo group (n = 30). All participants consumed either 2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks. The anthropometric measurements, blood samples, and questionnaire survey were collected again at 6-week, 12-week, 16-week, and 24-week. Data will be analyzed by two-way mixed design ANOVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
A double-blind, matched-pair study design
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •evaluated as sexual dysfunction for more than three months by physician
- •international index of erectile function (IIEF) score is less than or equal to 21
- •erectile hardness score (EHS) score is less than or equal to 3
- •aged over 18 years old
排除标准
- •unable to cooperate with the course of the treatment
- •suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
- •had Radical Prostatectomy (total removal of the prostate gland)
- •suffering from active tumors in the prostate or pelvic area
- •suffering from Hypogonadism
- •anatomical deformation of the penis
- •men with penile prosthesis
- •suffering from psychotic disorder (manic disorder, chronic depression, etc.)
- •suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
- •using Permanent pacemaker
- •considered unsuitable to participate in this experiment according to the doctor
- •alcohol or drug abuse
结局指标
主要结局
Level of FSH
时间窗: 24 weeks of supplementation
IIEF-5 score
时间窗: 24 weeks of supplementation
EHS score
时间窗: 24 weeks of supplementation
level of PSA
时间窗: 24 weeks of supplementation
Testosterone level
时间窗: 24 weeks of supplementation
LH level
时间窗: 24 weeks of supplementation
次要结局
未报告次要终点