A clinical study of Speman GNX Tablet for Low sperm count
- Conditions
- Health Condition 1: N461- Oligospermia
- Registration Number
- CTRI/2018/04/013437
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improve in the sperm count to normal level. <br/ ><br>2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value <br/ ><br>Timepoint: 1.Improve in the sperm count to normal level. <br/ ><br>2.Improvement sperm quality, sperm morphology and sperm motility, liquidation, semen volume and sperm density value <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Incidence of adverse events during the study period. <br/ ><br>2.Number of conceptions measured in the course of clinical trial.Timepoint: Visit 0- Screening Visit <br/ ><br>Visit 1- At entry visit <br/ ><br>Visit 2- At the end of day 30 <br/ ><br>Visit 3- At the end of day 60 <br/ ><br>Visit 4- (End of the treatment) At the end of day 90