Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial for Evaluation of Sperm Motility Improvement Effect of Fermented Ginseng(GINST)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Sperm motility
研究概览
简要总结
This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.
详细描述
This multicenter, randomized, double-blind, placebo-controlled clinical trial was aimed to evaluate of sperm motility improvement effect of fermented ginseng(GINST). Experimental arm and control arm were randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%.
To experimental arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided for 12 weeks. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These capsules are made of a cellulose component.
Primary outcome is sperm motility. Secondary outcome are <Brief Male Sexual Function Inventory> , <Fatigue Severity Scale>, and <the Short Form (36) Health Survey> measured at baseline and end of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
- Participant masking:
To intervention arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These apsules are made of a cellulose component. 2. Care provider masking The care providers will be unaware which participant belonged to the experimental group or control group during stuty period.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 18 and 60 years old
- •Men who have agreed to participate in this trial before the start of the study and who have written an informed consent
排除标准
- •Those who are diagnosed and treated for hypertension (systolic blood pressure> 140mmHg and diastolic blood pressure> 90mmHg)
- •Patients with a history of chemotherapy for malignant tumors
- •Patients with a history of taking testosterone or antiandrogens within 1 month
- •BMI> 30 or BMI <18
- •Those who have the following results in the blood test: AST(aspartate aminotransferase ), ALT(Alanine transaminase) > 2 times the upper limit of reference range; Serum Creatinine> 2.0 mg / dl
- •Those who ingested drugs (eg, folic acid, L-carn, HCG(human chorionic gonadotropin ), FSH(Follicle-stimulating hormone), Clomiphene, etc.) that have an effect on sperm motility within 2 weeks before the screening day.
- •Persons who have received antipsychotic medication within 2 months before the screening test
- •Those who have history of alcoholism or substance abuse
结局指标
主要结局
Sperm motility
时间窗: Change from baseline sperm motility at 12 weeks
Sperm motility is evaluated by Computer-Aided Semen Analysis, or CASA. Sperm motility will be expressed as '% motile' , the percent of cells that are motile. According to WHO definition, asthenozoospermia is regarded as falling below 40% motility in this study.
次要结局
- Sexual function(Change from baseline Sexual Function Inventory (questionnaire) at 12 weeks)
- Quality of life(Change from baseline quality of life at 12 weeks)
- Fatigue questionnaire(Change from baseline Fatigue Severity Scale at 12 weeks)
研究者
Jae Hoon Lee
Clinical Fellow
Severance Hospital