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The efficacy of Withania somnifera on spermogram in infertile men

Comparison the effect of Iranian Traditional Medicine product (based on Withania somnifera) with Pentoxifylline on sperm parameters in the infertile men, triple-blind randomized Clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015092224135N1
Enrollment
100
Registered
2016-01-28
Start date
2016-01-07
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Male Infertility. Diseases of male genital organs,Male infertility

Interventions

Intervention 1: In control group: receiving pentoxifylline, patients will receive 800mg of pentoxifylline granules +placebo powder daily in the form of 5 capsules in morning, noon, night for 3 mon
Treatment - Drugs
In control group: receiving pentoxifylline, patients will receive 800mg of pentoxifylline granules +placebo powder daily in the form of 5 capsules in morning, noon, night for 3 months
In receiving traditional medicine product group(Withania somnifera ), patients will receive 5 g of this product daily in the form of 5 capsules in morning,noon, night for 3 months

Sponsors

Vice chancellor for research,Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Patient satisfaction? Men 18-45 years? Infertility for at least one year with unexplained Oligo+/- astheno +/- teratozoospermia according to WHO criteria? Nonsmoking and nonaddiction to alcohol and drugs? No azospermia? No infections, No genital anatomical abnormalities? No risk of varicocele? No history of surgery on the genital tract? No Systemic diseases ( cancer, thyroid diseases, liver and gall bladder diseases, renal failure, diabetes, uncontrolled hypertension, cerebral hemorrhage , retina bleeding, etc)? No unilateral testicular atrophy? No history of taking chemotherapy, corticosteroid, anticoagulation,testosterone, antiandrogen. Exclusion criteria: Smoking or any kind of drug abuse during the study? Intaking any other chemical or herbal infertility drug during the study? Make any side effects from medication? The need for other interventions and surgery during the study? The reluctance of patients to continue.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sperm count. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Sperm analysis.;Sperm motility. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis.;Sperm morphology. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis.;Semen volume. Timepoint: At the begining of the trial,90 days after the intervention. Method of measurement: Semen analysis.

Secondary

MeasureTime frame
To determine the potential adverse events resulting from treatment process in patients in the intervention groups. Timepoint: during the study. Method of measurement: questionnaire-Observation-reportage.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Nasimi Doost Azgomi

School of Traditional Medicine, Tabriz University of Medical Sciences

Nasimir@tbzmed.ac.ir? Modir7060@yahoo.com+98 41 3337 9529

Outcome results

None listed

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