Comparative clinical evaluation of two species of Roscoea in Oligozoospermia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Dorbalya (genera debility)
研究概览
简要总结
This study is comparative clinical trial of two species of Roscoea in oligozoospermia.
This will be conducted on 60 male participants with oligozoospermia will be selected randomly from outdoor patients of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan, Haridwar. Subject will be selected irrespective of their religion, occupation. Patient will be divided randomly into two groups each group will have 30 patients on the basis of inclusion and exclusion criteria. Follow up will be taken after 30th day and 45th day of treatment.
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
- 21.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Sperm count mild oligozoospermia (10-15 million sperms /ml) & moderate oligozoospermia (5-10million sperms /ml)
- •Willing to sign the consent form and to participate in study.
- •Willing to give specimen of semen before and at the end of the clinical trial.
- •Abstinence during treatment.
排除标准
- •Azoospermia, Aspermia, Necrospermia
- •Patients with abnormal liver and renal functions test.
- •Subject with history of severe systemic illness like chronic renal failure, coronary artery disease, liver cirrhosis, cancer etc.
- •Varicocele, hydrocele, prostatitis, erectile dysfunction, male accessory gland infection.
- •History of undescended testis, mumps orchitis, inguinal hernia.
- •Known case of uncontrolled diabetes, hypertension, thyroid disease.
- •Sexually transmitted disease patients presenting with organic defects.
- •History of obstruction of ejaculatory ducts (seminal vesicle, vas deferens) postsurgical procedure or post trauma on the genital organs.
- •Testicular cancer and cancer treatment.
结局指标
主要结局
1. Dorbalya (genera debility)
时间窗: 30 days, 45 days
2. Mukhshosha
时间窗: 30 days, 45 days
3. Panduta (pallor)
时间窗: 30 days, 45 days
4. Shrama (easy fatigability)
时间窗: 30 days, 45 days
5. Sadan (boydache)
时间窗: 30 days, 45 days
次要结局
- 1. Semen analysis(2. CBC, RBS)
研究者
Jai Shree Yadav
Patanjali bhartiya ayurvigyan evam anusandhan sansthan haridwar uttarakhand