Skip to content

A randomized double-blind positive drug parallel controlled multi-center study on the treatment of Oligoasthenospermia(Shenyang insufficiency) in men with Shengjing Capsules

A randomized double-blind positive drug parallel controlled multi-center study on the treatment of Oligoasthenospermia(Shenyang insufficiency) in men with Shengjing Capsules

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001176
Enrollment
Unknown
Registered
2025-06-14
Start date
2026-03-31
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Oligoasthenospermia

Interventions

Asthenospermia Control group:Shengjing Capsules Simulation Agent+Compound Xuanju Capsule
Asthenospermia Experimental group:Shengjing Capsules +Compound Xuanju Capsule Simulation Agent
Oligozoospermia Control group:Shengjing Capsules Simulation Agent+Compound Xuanju Capsule
Oligozoospermia 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 at least one of the diagnostic criteria of male Oligozoospermia or Asthenospermia 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) There are gonadal dysplasia, hypogonadism, testicular atrophy, cryptorchidism, chronic epididymitis, and retrograde Ejaculation or no ejaculation, Y chromosome microdeletion, grade II or above varicocele, urinary tract infection, acute patients with diseases such as seminal vesiculitis and acute prostatitis; (2) Patients with a history of reproductive organ surgery or trauma that affects their reproductive function; (3) Those who take anti-epileptic, anti-tumor or other drugs that may hinder sperm production and sperm motility, etc. (4) Patients with abnormal sex hormones that have clinical significance; (5) There are serious primary diseases of the heart, liver, kidneys, hematopoietic system, endocrine system, respiratory system, etc. Patients with liver function ALT and/or AST higher than the upper limit of the reference value by more than 1.5 times, and renal function Scr higher than the upper limit of the normal value; (6) Combined with hypertension (Patients with persistent hypertension with systolic blood pressure >185mmHg or diastolic blood pressure>110mmHg after antihypertensive treatment) and patients with poor blood sugar control (glycosylated hemoglobin >7.5%),Patients with obesity (BMI=27) or accompanied by metabolic syndrome; (7) 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; (8) People with allergic constitutions, or those known to be allergic to the test drug and its components; (9) Patients with intellectual disabilities, mental disorders, etc., who may affect the evaluation of the trial; (10)Patients who are currently participating in other clinical trials or have participated in other drug clinical trials and have completed them within less than 3 months; (11)Patients with other conditions that the researcher deems inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Sperm concentration;Percentage of sperm forward movement;

Secondary

MeasureTime frame
Sperm concentration;Percentage of sperm forward movement;Total sperm count;Sperm survival rate and sperm motility;Total score of TCM syndromes and individual symptom scores;Efficacy of Traditional Chinese Medicine Syndromes;

Countries

China

Contacts

Public ContactLiancheng Jia

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: May 1, 2026