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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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.
- •11. Subject with abuse like smoking, alcohol etc.
- •12. Subjects having known hepatic or renal disease.
- •13. Subjects having an active malignancy.
- •14. Subjects having untreated/uncontrolled hypertension.
- •15. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
- •16. Subjects having Diabetes Mellitus.
- •17. Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •18. Known hypersensitivity to ingredients used in study drug.
- •19. Children and women will not be recruited in this study.
- •20. Occurrence of febrile illness, Temperature > 102 oF within 3 months prior screening.
- •21. Body Mass Index (BMI) > 35 kg/m2.
- •22. Subjects who have occupational / environmental exposures to risk factors for male reproductive System, e.g. chronic heat exposure, ionizing radiation, heavy metals like lead, cadmium, certain pesticides, frequent sauna bath etc.
研究者
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