CTRI/2012/09/002950
已完成
2 期
â??A Randomized, Double Blind, Placebo Controlled, Multi-center, Parallel Group, Clinical Study to Evaluate Efficacy and Safety of â??TLPL/AY/04/2009â?? in Patients Suffering from Male Infertility.â?? - NI
Tulip Lab Private Limited0 个研究点目标入组 40 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: null- Male Infertility
- 发起方
- Tulip Lab Private Limited
- 入组人数
- 40
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Married male subjects between 21 to 45 years of age.
- •2\. Subjects with the history of minimum 1 year of regular unprotected sexual activity without achieving pregnancy.
- •3\. Subject having Sperm concentration (sperm count; sperm/ml) \< 15 millions/ml.
- •4\. Subject having semen volume (total volume of ejaculate) not to be \< 1\.5 ml per ejaculate,
- •5\. Subject with or without Sperm total motility less than 40% or sperm forward progressive motility less than 32%.
- •6\. Subject having Normal sperm morphology.
- •7\. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1\. Subjects with abnormal laboratory investigation(s) (above or below normal range) with corresponding clinical symptoms will not be recruited in the trial.
- •2\. Subjects demonstrating hemospremia, leucospermia, absence of fructose or pH \< 7\.2 or \> 8\.0 hyperspermia i.e. \> 7 ml ejaculatory volume.
- •3\. Subjects having Klinefelterâ??s Syndrome, Kartagener Syndrome.
- •4\. Congenital anomalies â?? spine bifida, congenital bilateral/unilateral absence of vas deference.
- •5\. Subject whose ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
- •6\. Subject whose X\- ray chest showing any active lesion of Tuberculosis.
- •7\. Subject whose USG and/or colour Doppler of testes showing hydrocele, varicocele, orchitis, and epididymitis or any other abnormal findings, will not be recruited in the trial.
- •8\. Subjects showing high serum prolactin levels will not be recruited in the trial.
- •9\. Subjects having active metabolic or gastrointestinal diseases or any kind of physical anamoli that may interfere with spermatogenetic process or pathway.
- •10\. Subject having drug dependency or failure to keep abstinence for antioxidant agents, vitamins, anti\-inflammatory drugs, hormones, herbal /homeopathic medications.
结局指标
主要结局
未指定
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