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Clinical observation of Bixie Qianlie An Pills in the treatment of infertile patients with varicocele and ssthenospermia syndrome of kidney deficiency, dampness-heat and blood stasis syndrome

Observation on the Efficacy of Bixie Qianlie An Pills in the Treatment of Infertile Patients with Varicocele Complicated with Asthenospermia and Syndrome of Kidney Deficiency, Dampness-Heat and Blood Stasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002261
Enrollment
Unknown
Registered
2025-11-21
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

varicocele and ssthenospermia syndrome of kidney deficiency, dampness-heat and blood stasis syndrome

Interventions

Observation group: Administer Bixie Qianlie An Pills oral solution
Control group:Administer L-carnitine oral solution

Sponsors

Zhengzhou City, Henan Province; Henan Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 40 Years

Inclusion criteria

Inclusion criteria: Based on the "Guidelines for Clinical Research of New Chinese Medicines", the following are the requirements: a. Meets the diagnostic criteria for mild male infertility in Western medicine; b. Meets the diagnostic criteria for traditional Chinese medicine syndromes; c. Age between 22 and 40 years old; d. The female reproductive system examination is normal; e. The patient voluntarily signs the informed consent form; f. The male reproductive system is developed normally, and has regular sexual life. Voluntarily participate in this clinical trial study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: According to the "Chinese Expert Consensus on the Diagnosis and Treatment of Asthenospermia", "Chinese Expert Consensus on the Diagnosis and Treatment of Oligospermia", and "Chinese Expert Consensus on the Diagnosis and Treatment of Teratozoospermia", the following exclusion criteria are established: (1) Individuals under 20 years old or over 40 years old; (2) Severe asthenospermia with PR < 10%; (3) Those with congenital organic lesions or malformations of the reproductive organs; (4) Patients with oligospermia, immune infertility, or teratozoospermia; (5) Those with retrograde ejaculation or anejaculation and other sexual dysfunction; (6) Patients with primary diseases such as cardiovascular and cerebrovascular diseases and autoimmune reactions or severe mental illness that prevent them from cooperating with systematic treatment; (7) Long-term users of Western medicine and those taking drugs with reproductive toxicity; (8) Those with long-term smoking, drinking, and irregular sexual life; (9) Those with endocrine and liver and kidney function abnormalities; (10) Patients with seminal vesiculitis, epididymitis, acute prostatitis, orchitis, and other reproductive and urinary tract infections and reproductive tract obstructions; (11) Those with grade III varicocele with DR = 3.1mm. Meeting any of the above criteria qualifies as meeting the exclusion criteria.

Design outcomes

Primary

MeasureTime frame
Spouse's pregnancy status;Forward motility of spermatozoa;Total sperm motility;The maximum inner diameter during the Valsalva test;Semen antioxidant-related indicators: Superoxide dismutase;Prostate fluid malondialdehyde;reactive oxygen;Duration of continuous reflux;The maximum inner diameter of the spermatic vein during normal breathing;

Secondary

MeasureTime frame
The improvement of symptoms in traditional Chinese medicine;

Countries

China

Contacts

Public Contactshengyue Wang

Department of Andrology, Henan Provincial Hospital of Traditional Chinese Medicine, No. 6 Dongfeng Road, Jinshui District, Zhengzhou City, Henan Province

hnszyylsl@126.com13937105328

Outcome results

None listed

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