A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate the Efficacy and Safety of Speman GNX Tablet in Oligospermia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.Improve in the sperm count to normal level.
研究概览
简要总结
This is A Randomized, Double blind, Placebo controlledClinical Study to Evaluate the Efficacy and Safety of Speman GNX Tablet inOligospermia for the treatment of male infertility. This formulationis intended to improve sperm count, sperm quality, sperm morphology,motility. In this study, 60 cases will be enrolled. 30 patients each intrial group and placebo group and advised to take the study drug for a periodof 90 days.
The Investigational product will be one of theformulations either Speman GNX tablet or placebo which is as per therandomization with dose of one tablet twice daily for 90 days. Patients will befollowed up for Clinical assessment, and lab examination at screening andat end of study visit. Semen analysis will be done at Entry, Day 30, Day60 and Day 90.
The present study showed that subjects treated with SpemanGNX tablet showed significant improvement in oligospermia. There was significantimprovement in semen volume, sperm count, pH was maintained at normal range,increased sperm motility and improved sperm morphology as compared to placebo. Thehormonal parameters like testosterone was normalised in Speman Gnx group. In Speman GNX group there was a trend of improvement from Day 30 onwards. Overall response to Speman GNX in oligospermia wasfound to be good. The efficacy of Speman GNX tablets can be attributedto the synergistic actions of the potent herbs present in the formulation. Therewas no improvement seen in the placebo group. Present study indicates that Speman GNX is safeand effective in the management of oligospermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Healthy males 21-45 years of age with infertility for more than 3 months, diagnosed with Oligospermia (Defined by < 15 million sperms/ ml) as per the WHO standards 2.No past history of renal, hepatic or any other chronic illness in the past 3.Normal liver and renal functions tests 4.Patients freely willing and able to provide written informed consent, willing to follow study procedures.
排除标准
- •Complete azoospermia in pre-treatment samples -Any congenital anomaly resulting in oligospermia -Evidence of male accessory gland infection, -Any recent medical or surgical illness, -Hormone/ any other treatment for promoting fertility in the last three months.
- •The patients with undescended testis, evidence of thyroid diseases, inguinal hernia, moderate to moderate to severe diabetes with complications and other systemic diseases requiring specific therapies will be excluded from the study.
- •Not willing to provide the informed consent form.
结局指标
主要结局
1.Improve in the sperm count to normal level.
时间窗: 1.Improve in the sperm count to normal level. | 2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value
2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value
时间窗: 1.Improve in the sperm count to normal level. | 2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value
次要结局
- 1.Incidence of adverse events during the study period.(2.Number of conceptions measured in the course of clinical trial.)