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A randomized, double-blind, placebo-controlled, multicenter clinical study of Gulingji for treatment of patients with idiopathic oligoasthenoteratospermia

A randomized, double-blind, placebo-controlled, multicenter clinical study of Gulingji for treatment of patients with idiopathic oligoasthenoteratospermia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054837
Enrollment
Unknown
Registered
2021-12-28
Start date
2020-09-01
Completion date
Unknown
Last updated
2022-12-12

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

Conditions

Idiopathic Oligoasthenoteratospermia

Interventions

Control group:Placebo

Sponsors

Eastern Theater General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with oligoasthenospermia according to the "World Health Organization Laboratory Manual for the Examination and Processing of Human Semen (Fifth Edition)"; 2. Abnormal semen quality in the initial examination and re-examination, meeting one of the following conditions: sperm density < 15 x 10^6/mL or total sperm count < 39 x 10^6, forward motile sperm ratio < 32% or total sperm motility The percentage of spermatozoa with normal morphology is less than 40%, and the total number of motile spermatozoa is more than 5 x 10^6.

Exclusion criteria

Exclusion criteria: 1. With testicular, epididymitis, prostatitis, severe genital trauma, testicular torsion, urinary tract infection, cryptorchidism, varicocele, and serious medical diseases such as diabetes, history of tumor, history of groin and genital surgery ; 2. Testicular volume 32; 4. Abnormal karyotype; 5. Patients with Yin deficiency and Fire Prosperity syndrome (clinical features: dry mouth and throat, five upsets and heat, prone to oral ulcers, slightly red and dry tongue); 6. Patients with endocrine diseases; 7. Exposure to occupational or environment with reproductive toxicity; 8. Medications to improve semen quality have been used in the past 2 weeks; 9. Hepatobiliary disease, severe renal insufficiency, clinical disease or medication history known to reduce fertility; 10. Known or suspected history of allergy to test drugs and similar products; 11. Any situation that the investigator believes may interfere with participation in the study or evaluation.

Design outcomes

Primary

MeasureTime frame
Total sperm count in forward motion;

Secondary

MeasureTime frame
Sperm DNA fragmentation rate;

Countries

China

Contacts

Public ContactYao Bing

Eastern Theater General Hospital

yaobing@nju.edu.cn+86 13815853296

Outcome results

None listed

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