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A multicenter, randomized, open, positive controlled clinical trial on the efficacy and safety of Wuziyanzong pills in the treatment of asthenospermia (nephrospermia deficiency type)

A multicenter, randomized, open, positive controlled clinical trial on the efficacy and safety of Wuziyanzong pills in the treatment of asthenospermia (nephrospermia deficiency type) - A multicenter, randomized, open, positive controlled clinical trial on the efficacy and safety of Wuziyanzong pills in the treatment of asthenospermia (nephrospermia deficiency type)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072563
Enrollment
Unknown
Registered
2023-06-16
Start date
2023-06-19
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Asthenospermia

Interventions

Treatment group:Wuziyanzong pills

Sponsors

Xiyuan Hospital of CACMS
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Married men aged 22 to 40 (including 22 and 40); (2) Meet the diagnostic criteria for male infertility; (3) meet the Western diagnostic criteria for asthenospermia; (4) Conforming to TCM syndrome differentiation standards of kidney and essence deficit syndrome; (5) normal development of reproductive organs; (6) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Infertility caused by chromosomal abnormalities (such as heterotopic Rothschild, Y chromosome microdeletion, etc.); (2) spermatic obstruction, varicocele or cryptorchidism; (3) orchitis, epididymitis, mycoplasma, chlamydia infection and other diseases affecting semen quality; (4) various causes of vaginal ejaculation dysfunction, such as no ejaculation, retrograde ejaculation and other sexual dysfunction; (5) Severe hepatic and renal insufficiency (alanine aminotransferase (ALT)>3×ULN, aspartate aminotransferase (AST)>3×ULN, urea nitrogen (BUN)>2×ULN, creatinine (Cr)>1×ULN), cardiovascular and cerebrovascular diseases, hematopoietic diseases; (6) Patients with poorly controlled hypertension (systolic blood pressure >160mmHg and/or diastolic blood pressure >100mmHg) or diabetes (fasting blood glucose >7mmol/L); (7) serious mental illness accompanied by mental abnormality or loss of self-care ability; (8) Allergic to the experimental drug; (9) Patients with chronic addiction to smoking or drinking that may affect their fertility, or those who cannot ban smoking or alcohol during the experiment, the specific criteria are as follows: ? Smoking history: those who smoked more than 5 cigarettes per day in the past 6 months; ? Drinking history: the average daily alcohol consumption in the past 6 months exceeded the following standards: beer 570 ml, red wine 200 ml or white wine 60 ml, each containing about 20 g alcohol; (10) Those who have failed to take the test drug before, or had adverse reactions that could not be tolerated; (11) Use of drugs that improve or affect sperm concentration or motility 1 month before screening; (12) Participants who had participated in other clinical trials within 3 months before screening; (13) According to the judgment of the investigator, there are others who are not suitable to participate in this clinical trial. (6) Voluntary signing of informed consent.

Design outcomes

Primary

MeasureTime frame
PR sperm rate;

Secondary

MeasureTime frame
PR sperm rate;PR+NP sperm rate;Total effective sperm count;Change value of TCM syndrome score;Spouse pregnancy rate;Sperm DNA fragmentation index;

Countries

China

Contacts

Public ContactJun Guo

Xiyuan Hospital of CACMS

guojun1126@126.com+86 139 1127 2060

Outcome results

None listed

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