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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
ITMCTR
Registry ID
ITMCTR2100005458
Enrollment
Unknown
Registered
2021-12-28
Start date
2020-09-01
Completion date
Unknown
Last updated
2023-02-20

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

Jinling Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed as oligoasthenospermia according to the World Health Organization Laboratory Manual for Human Semen Examination and Treatment (5th edition); 2.Initial examination and reexamination of abnormal semen quality shall meet one of the following conditions: sperm density 5×10^6;

Exclusion criteria

Exclusion criteria: Leucospermia, with testis, epididymitis, prostatitis, severe genital trauma, testicular torsion, urinary tract infection, cryptorchidism, varicocele, and a history of serious medical conditions such as diabetes, tumor history, inguinal and genital surgery. Testicular volume 32. Chromosomal karyotype abnormalities. Patients with Yin deficiency syndrome (clinical features: dry mouth and pharynx, five upset heat, prone to oral ulcers, slightly red and slightly dry tongue). Patients with endocrine diseases. Exposure to an occupation or environment with reproductive toxicity. Drug therapy to improve semen quality has been used in the past 2 weeks. Hepatobiliary disease, severe renal insufficiency, clinical disease or history of medication known to reduce fertility. A known or suspected history of allergy to experimental drugs and similar products. Any circumstance that the investigator considers to be likely to interfere with participation in the study or assessment.

Design outcomes

Primary

MeasureTime frame
Total sperm count in forward motion;

Secondary

MeasureTime frame
Sperm DNA fragmentation rate;

Countries

China

Contacts

Public ContactYao Bing

Jinling Hospital

yaobing@nju.edu.cn13815853296

Outcome results

None listed

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