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Epimedium glycoside for the treatment of varicocele-related heat stress male infertility (Kidney deficiency and blood stasis syndrome): A clinical study

Epimedium glycoside for the treatment of varicocele-related heat stress male infertility (Kidney deficiency and blood stasis syndrome): A clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001182
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Varicocele-associated heat stress male infertility disease

Interventions

Intervention Group (Epimedium Group):The experimental group adopted the principle of postoperative basic treatment combined with Epimedium extract intervention. Patients who met the diagnostic criteri
Control Group:Select patients with the same clinical profile as the intervention group, who after undergoing microsurgical varicocelectomy, are administered an equivalent amount of placebo for 30 cons

Sponsors

Nanjing Medical University the Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for varicocele according to Western medicine; (2) Meets the diagnostic criteria for kidney deficiency and blood stasis syndrome according to Traditional Chinese Medicine (TCM); (3) Sperm concentration: 1×10^6/ml = sperm concentration <15×10^6/ml or 1% = PR <32%; (4) Patient age: 18 years = age =60 years; (5) Voluntarily participates in this clinical trial and signs the written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Congenital obstructive azoospermia, genital malformations, secondary varicocele, including nutcracker syndrome, and varicocele caused by compression from abdominal or retroperitoneal tumors; (2) Patients with severe oligozoospermia and severe asthenozoospermia; Criteria: Sperm concentration <1×10^6/mL, sperm progressive motility (PR) <1%; (3) Patients who have taken medications related to the treatment of this disease, specifically kidney-nourishing and sperm-generating drugs, within the past month; (4) Patients with severe underlying primary diseases of the heart, liver, kidneys, or other systems, or mental disorders; (5) Patients with known allergies to any components of the investigational drug; (6) Patients who have participated in other clinical trials within the past three months prior to randomization; (7) Patients deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Sperm concentration;sperm forward motility;testicular volume;Semen Biochemical Analysis;

Secondary

MeasureTime frame
Visual Analogue Scale;Sperm DNA Fragmentation Rate;Maximum diameter of the spermatic vein (under Color Doppler Flow Imaging) during Valsalva maneuver.;

Countries

China

Contacts

Public ContactDeng Zhonglei

Department of Urology, the Second Affiliated Hospital of Nanjing Medical University.

dzl840564@126.com15951823070

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026