A Multicenter, Randomized, Double-blind, Positive Drug Controlled Clinical Trial on the Efficacy and Safety of Guilu Erxian Oral Liquid in the Treatment of Oligozoospermia and Asthenospermia With Syndrome of Shen (Kidney) Essence Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Total number of anterograde motile sperm (TPMSC)
研究概览
简要总结
The main function of Guilu Erxian Oral Liquid is to warm the shen (kindney) and replenish essence. It is used for chronic shen (kindney) deficiency, waist and knee weakness, spermatorrhea and impotence. The treatment of deficiency of kidney essence and asthenospermia is to invigorate the shen (kindney) and replenish the essence, nourish the shen (kindney) and assist the essence. The idea of combining traditional Chinese and western medicine is to move the yang and calm the yin, and traditional Chinese medicine is mainly to invigorate the shen (kindney) and replenish the essence. In order to better provide the basis for clinical medication and meet the treatment needs of oligozoospermia and asthenospermia, this trial is intended to evaluate the effectiveness and safety of Guilu Erxian oral liquid in treating oligozoospermia and asthenospermia with Syndrome of Shen (Kidney) Essence Deficiency subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Married men aged 22 to 40;
- •Meet the diagnostic criteria of male infertility;
- •Meet the diagnostic criteria for mild and moderate oligozoospermia, asthenospermia and oligoasthenospermia;
- •Meet the TCM syndrome differentiation standard of Shen (kidney) essence deficiency syndrome;
- •Sign the informed consent form voluntarily.
排除标准
- •Infertility due to chromosome abnormalities (such as Roche heterotopia, Y chromosome microdeletion, etc.);
- •Varicocele or cryptorchidism;
- •Diseases affecting semen quality such as orchitis, epididymitis, mycoplasma and chlamydia infection;
- •Anejaculation, retrograde ejaculation and other sexual dysfunction;
- •Severe liver and kidney dysfunction (alanine aminotransferase (ALT)>1.5 × ULN, aspartate aminotransferase (AST)>1.5 × ULN, blood urea nitrogen (BUN)>2 × ULN, Cr>1 × ULN), disease of cardiovascular and cerebrovascular system, disease of hematopoietic system;
- •Hypertension (systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg) or diabetes (fasting blood glucose > 7mmol / L) with poor drug control;
- •Serious mental illness, accompanied by mental disorder or loss of self-care ability;
- •Those who are allergic to the test drug;
- •Those who have long term bad habits such as smoking and drinking, which may affect fertility, or those who cannot ban smoking and drinking during the test, the specific criteria are as follows:
- •①History of smoking: Those who have smoked more than 5 cigarettes per day in the past 6 months;
- •②History of drinking: in the past 6 months, the average daily consumption of alcohol exceeded the following standards: 570 ml of beer, 200 ml of wine or 60 ml of spirit, each containing about 20 g of alcohol;
- •Those who have been unable to take the test drug in the past or have intolerable adverse reactions;
- •Those who used drugs to improve or affect sperm concentration or motility 1 month before screening;
- •Those who have participated in other clinical trials within 3 months before screening;
- •According to the judgment of the investigator, there are other persons who are not suitable to participate in this clinical trial.
研究组 & 干预措施
Guilu Erxian Oral Liquid
干预措施: Guilu Erxian Oral Liquid (Drug)
Wuzi Yanzong oral liquid
干预措施: Wuzi Yanzong oral liquid (Drug)
结局指标
主要结局
Total number of anterograde motile sperm (TPMSC)
时间窗: 4,8,12 weeks after medical treatment
Total number of anterograde motile sperm (TPMSC), the change value from the baseline
次要结局
- TCM syndrome score(4,8,12 weeks after medical treatment)
- Semen routine parameters: sperm concentration (SC), total sperm count (SPE-C), percentage of sperm forward movement (PR,%), total sperm vitality (PR+NP,%)(4,8,12 weeks after medical treatment)
- Pregnancy rate of spouse/partner(4,8,12,24 weeks after medical treatment)
- Male reproductive endocrine hormones: testosterone (T), follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL)(12 weeks after medical treatment)
- Sperm DNA fragment index, which is used for sperm DNA integrity analysis(12 weeks after medical treatment)