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A clinical study of Speman GNX Tablet for Low sperm count

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate the Efficacy and Safety of Speman GNX Tablet in Oligospermia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013437
Enrollment
60
Registered
2018-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N461- Oligospermia

Interventions

Intervention1: Speman GNX tablet: 1 tablet twice daily Control Intervention1: Placebo: One tablet twice daily

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy males 21-45 years of age with infertility for more than 3 months, diagnosed with Oligospermia (Defined by 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

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 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

Secondary

MeasureTime frame
1.Incidence of adverse events during the study period. 2.Number of conceptions measured in the course of clinical trial.Timepoint: Visit 0- Screening Visit Visit 1- At entry visit Visit 2- At the end of day 30 Visit 3- At the end of day 60 Visit 4- (End of the treatment) At the end of day 90

Countries

India

Contacts

Public ContactDr Palaniyamma

Pearl Health Care

srinivasan.thimmaraju@gmail.com8072033356

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026