Randomized uncontrol clinical trial of efficacy of shatavaryadi churna in shukrakshaya with special reference to oligospermia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Reduction in signs and symptoms of shukrakshaya and increase in sperm concentration
研究概览
简要总结
The prevalence rate of oligospermia in India is 21.43%.The need to have children is of great priority in families hence treatment of infertility has become a global concern.Tje couple not able to reproduce experiences the feeling of frustration and disappointment which increase oxidative stress level thereby worsening the condition.In modern science there is no effective treatment available for oligospermia.The primary treatment for shukrakshaya is vrushya chikitsa.Shatavaryadi churna has properties like vrushya, rasayan, bruhan.As previously no study has been done on shatavaryadi churna in shukrakshaya.so it will be helpful in male age group between 25 to 45 years having sign and symptoms of shukrakshaya and low sperm concentration.Written informed consent will be taken to ensure compliance and transparency in research process.The sample size calculated is 23 by sample size formula.Simple random sampling technique will be used.It is a single ram study.All SOP of churna will be followed throughout the clinical trial.Observation will be done after semen analysis report.Result will be drawn on the basis of assessment criteria.Statistical discussion will be done on the basis of observation and result obtained during treatment.Summary will be drawn,and thesis will be summarized with the help of statistical analysis.Conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Male
入选标准
- •Age above 25 year and below 45 years 2.Patient having total sperm concentration less than 15million per ml.
- •3.Patient with clinical presentation of shukrakshaya with semen sample suggestive of oligospermia.
排除标准
- •Patient with diseases like varicocele in scrotum,hydrocele etc 2)Sexually transmitted disease 3)All congenital cases of impotency(As klaibya in ayurvedic texts) 4)Post surgical complications and traumatically injured condition of genital organs.
结局指标
主要结局
Reduction in signs and symptoms of shukrakshaya and increase in sperm concentration
时间窗: 18 month
次要结局
- Comparing semen analysis report before & after giving shatavaryadi churna for 1 month(1 month)
研究者
Rinkal Sarkarsing Rajput
Hon. Shree Annasaheb Dange Ayurved Medical College, Ashta Tal-Walwa Dist-Sangli
