An Clinical Trial on the Efficacy and Safety of Shen Hai Long Capsule in the Treatment of Male Asthenospermia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Forward motile sperm ratio (PR)
研究概览
简要总结
To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men.
详细描述
To evaluate the efficacy and safety of Shen Hai Long Capsule in the treatment of mild to moderate asthenospermia in men: 1) Efficacy index (1) Main efficacy indexes Forward motile sperm ratio (PR) (2) Secondary efficacy indexes 1. Sperm survival rate; 2. Sperm concentration; 3. Normal morphology rate of sperm; 4. Seminal malondialdehyde (MDA) 5. Seminal superoxide dismutase (SOD) 2) Safety indicators
(1) Vital signs; (2) liver and kidney function; (3) blood routine; (4) electrocardiogram; (5) Adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age range from 22 to 50 years old;
- •Patients with mild to moderate asthenospermia, that is, at least two normative semen analyses indicated that 10%≤PR percentage < 32% and the total number of PR sperm ranged from 5 million to 20 million;
- •At least two standard semen analyses indicated that sperm concentration ≥15×106 /ml; Sperm normal morphology rate ≥4%;
- •No other Chinese and Western drugs for the treatment of oligospermia, weak and malformed spermia have been taken in the past 3 months;
- •The subject voluntarily participates and signs the informed consent.
排除标准
- •Varicocele, ejaculatory duct/seminal vesicle cyst, anti-sperm antibody (+);
- •Genital tract infection: seminal plasmic elastase > 1000ng/ml or leukocyte semen disease (peroxidase positive cell concentration in semen more than 1×10^6/mL);
- •Erectile dysfunction, ejaculation disorders;
- •suffer from mental disorders, immune system diseases; Severe impairment of liver and kidney function (serum transaminase ≥2× upper limit of medical reference value, creatinine clearance ≤40ml/min or active stage of chronic kidney disease);
- •Patients with allergic history or constitution to therapeutic drugs;
- •Patients who have taken drugs affecting the study within 3 months, such as antitumor and antiepileptic drugs, etc.
研究组 & 干预措施
Shen Hai Long Group
干预措施: Shen Hai Long Capsule (Drug)
Sheng Jing Group
干预措施: Sheng Jing Capsule (Drug)
结局指标
主要结局
Forward motile sperm ratio (PR)
时间窗: 12 weeks
To compare the PR between baseline and 12 weeks
次要结局
- Sperm survival rate(12 weeks)
- Sperm concentration(12 weeks)
研究者
Yuanzhen Zhang
Prof
Zhongnan Hospital