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A randomized, double-blind, parallel-controlled, multi-center clinical trial of Shengjing capsule in the treatment of male semen non-liquefaction (kidney-yang deficiency syndrome)

A randomized, double-blind, parallel-controlled, multi-center clinical trial of Shengjing capsule in the treatment of male semen non-liquefaction (kidney-yang deficiency syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001760
Enrollment
Unknown
Registered
2025-09-16
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Unliquefiable semen

Interventions

Control group:Semen Simulator Compound Xuanju Capsule
Experimental group:Shengjing Capsules +Compound Xuanju Capsule Simulation Agent

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1)Male aged 22 to 50 (inclusive); (2) Patients who meet the diagnostic criteria for male Unliquefiable semen in Western medicine; (3) Patients who meet the diagnostic criteria for ShenYang deficiency syndrome in traditional Chinese medicine; (4) Voluntarily sign the informed consent form)

Exclusion criteria

Exclusion criteria: (1) Tuberculosis tumors urethral stricture interstitial cystitis neurogenic bladder or ureaplasma urealyticum sensation Dye; (2) There are gonadal dysplasia hypogonadism testicular atrophy cryptorchidism chronic epididymitis and retrograde conditions Ejaculation or no ejaculation Y chromosome microdeletion grade II or above varicocele urinary ract infection acute Patients with diseases such as seminal vesiculitis and acute prostatitis; (3) Patients with a history of mumps hernia or sexually transmitted diseases; (4) Patients with a history of reproductive organ surgery or trauma that affects their reproductive function; (5) Patients taking anti-epileptic anti-tumor or other drugs that may affect semen quality; (6) Have received infertility treatment measures semen liquefaction time treatment measures or sperm quality treatment measures within the past one month Patients undergoing quantitative treatment measures; (7) There are serious primary diseases of the heart liver kidneys hematopoietic system endocrine system respiratory system etc. Liver function ALT and/or AST are more than 1.5 times higher than the upper limit of the reference value and renal function Scr is higher than the upper limit of the normal value; (8) Combined with hypertension (Patients with persistent hypertension where systolic blood pressure >185 mmHg or diastolic blood pressure > 110 mmHg despite antihypertensive treatment), those with poor blood sugar control (HbA1c > 7.5%), Patients with obesity (BMI=27) or accompanied by metabolic syndrome; (9) Having a long-term and excessive habit of smoking and drinking or being exposed to high-temperature radioactive or toxic chemical environments but not Patients who can change or give up; (10) People with allergic constitutions or patients known to be allergic to the test drug and its components; (11) Patients with intellectual disabilities mental disorders etc. who may affect the evaluation of the trial; (12) Currently participating in other clinical trials or having participated in other drug clinical trials that have ended within less than three months (13)Patients with other conditions that the researcher deems inappropriate to participate in this study

Design outcomes

Secondary

MeasureTime frame
Proportion of subjects semen liquefaction time<60min;Proportion of subjects with semen liquefaction time<30min ;Changes of total sperm count, sperm motility from baseline;Total score of TCM syndromes and individual symptom scores;Efficacy of TCM medicine syndrome treatment;

Primary

MeasureTime frame
Proportion of subjects with semen liquefaction time<60min ;

Countries

China

Contacts

Public ContactJia Liancheng

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

drjialiancheng@sina.com13651367880

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026