A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study of Gulingji Capsule in the Treatment of Idiopathic Oligospermia, Asthenia, and Teratozoospermia.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- TNPMS
研究概览
简要总结
The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule.
详细描述
The WHO defines infertility as a condition in which a couple cohabitates and has normal sex, has not used contraception for more than a year and the woman has not been able to conceive naturally.Some male infertility patients who cannot find related infertility factors are called idiopathic male infertility.These male infertility patients are often characterized by abnormal sperm count (including oligospermia, azoospermia, occult sperm), abnormal motility (including asthenospermia, asthenospermia), or malformed sperm, collectively referred to as idiopathic oligospermia (idiopathic OAT).
At present, the treatment methods of idiopathic OAT are mostly empirical treatment, including anti-oxidation treatment, treatment to improve cell energy metabolism, treatment to improve microcirculation of the whole body and reproductive system, etc.In general, traditional Chinese treatment should be combined with traditional Chinese medicine.However, the relevant mechanism of TCM treatment of OAT is not yet clear.
The object of study for patients with idiopathic disease of OAT, the use of multicenter, randomized, double-blind, controlled, prospective clinical research, choose according to row, standard units of idiopathic male infertility clinics less weak abnormal sperm, randomly divided into experimental group and the placebo group, the comparison between the two groups of patients and semen parameters before and after medication, seminal plasma hormone, serum lipid levels and other indicators;At the same time, serum and seminal plasma samples of the two groups of patients before and after treatment were collected for bioinformatics analysis of protein spectrum to find the effector molecules of Gulingji capsule.
It is assumed that the probable case loss rate in the trial is 20%, with 120 cases in each group, and a total of 240 cases are required.
Drug treatment: Gulingji capsule was taken orally for 2 capsules, once before breakfast and dinner, and was taken with saline solution. The total treatment period was 90 days.(Placebo is rice flour)
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
- Double (Participant, Investigator)
盲法说明
The group randomization method was adopted according to the central stratification, and a total of 240 cases were randomly assigned equally to the experimental group and the control group by SAS 9.2 statistical system programming to generate a random allocation sequence table. Sequence table according to the distribution of drugs for blind packaging, medicine make blind by the personnel not to participate in clinical trials according to the generated random distribution plans and standard operating procedures for blind of experimental drugs allocation coding, coding procedure shall monitor, after completion of blind plait blind bottom seal should be in duplicate, respectively by the eastern theatre, head of the general hospital drug clinical trial institution and subject to save. SAS programs that generate randomization and related parameters are saved together with the blind end.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition);
- •initial examination and reexamination of abnormal semen quality shall meet one of the following conditions: sperm density < 15×10^6 / mL or total sperm count < 39×10^6, proportion of forward motile sperm < 32% or total sperm viability < 40%, percentage of normal sperm < 4%.
排除标准
- •Leucospermia, with testis, epididymitis, prostatitis, severe genital trauma, testicular torsion, urinary tract infection, cryptorchidism, varicocele, and a history of serious medical conditions such as diabetes, tumor history, inguinal and genital surgery.
- •Testicular volume < 12ml (B-ultrasonic measurement).
- •BMI < 18.5 or >
- •Chromosomal karyotype abnormalities.
- •Patients with endocrine diseases.
- •Exposure to an occupation or environment with reproductive toxicity.
- •Drug therapy to improve semen quality has been used in the past 2 weeks.
- •Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility.
- •A known or suspected history of allergy to experimental drugs and similar products.
- •Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.
研究组 & 干预措施
Experimental group
Guilingji capsule Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days.
干预措施: Guilingji Capsule (Drug)
Control group
Placebo Take 2 tablets orally, once before breakfast and dinner, and take them with saline. The total treatment period is 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
TNPMS
时间窗: 1 years
Total sperm count in forward motion
次要结局
- DFI(1 years)
研究者
Bing Yao
Reproductive Medicine Center
Jinling Hospital, China