CLINICAL STUDY ON AAN MALADU(MALE INFERTILITY)AND DRUG OF CHOICE IS VEERIYA VIRUTHI CHOORANAM.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome is mainly assessed by increase in the sperm count and motility %
研究概览
简要总结
It is a single, non-randomized, open-label trial to determine the efficacy and safety of VEERIYA VIRUTHI CHOORANAM (Prepared with eleven herbal constitutents in equal proportion) in patients with Aan maladu (Male infertility).In this trial 40 male infertility patients will be recruited and the trial drug will be administered 8 gms twice a day along with milk for a period of 90 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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.Male infertile 2.Age 21- 45 year 3.Maritial status.
- •more than 1 year 4.Sperm count ≤ 40 million / ejaculation 5.Motility less than ≤ 50 % 6.Patient is willing to sign the informed consent stating that he will continuously stick to the treatment during 48days but can opt out of the trial of his own conscious discretion. 7.Patients who are willing to give specimen of blood , urine and semen before and after treatment.
排除标准
- •1.Azoospermia 2.Hydrocele 3.Diabetes mellitus 4.Hypertension 5.Endocrine disorders 6.Caridiac diseases 7.VDRL & STD 8.Inguinal Hernia 9.Renal diseases 10.Varicose veins.
结局指标
主要结局
Outcome is mainly assessed by increase in the sperm count and motility %
时间窗: PRE STUDY SCREENING AND AFTER TREATMENT
次要结局
- CLINICAL ASSESSMENT(PRE STUDY SCREENING AND AFTER TREATMENT)