Skip to content

Clinical study on NIH-CPSI score of Xialiqi capsule ameliorating Type III Prostatitis ( Syndrome of Spleen-Kidney Qi Deficiency and Damp-Heat Stasis)

Clinical study on NIH-CPSI score of Xialiqi capsule ameliorating Type III Prostatitis ( Syndrome of Spleen-Kidney Qi Deficiency and Damp-Heat Stasis)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005669
Enrollment
Unknown
Registered
2022-02-28
Start date
2022-02-16
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

Type III Prostatitis

Interventions

Control group:Tamsulosin Hydrochloride Sustained Release Capsule, 0.2mg, qn
Experimental group:Xialiqi capsule, 3 capsules, tid+Tamsulosin Hydrochloride Sustained Release Capsule, 0.2mg, qn

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) It conforms to the diagnostic criteria of Type III Prostatitis. (2) It conforms to the standard of Syndrome of Spleen-Kidney Qi Deficiency and Damp-Heat Stasis. (3) Aged between 18 and 50. (4) NIH-CPSI=10. (5) Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with type I, II and IV prostatitis. (2) Those who have used drugs or other related treatments for chronic prostatitis in the past 2 weeks. (3) Patients with benign prostatic hyperplasia, prostate tumor, epididymitis, seminal vesiculitis, urinary tract disease, severe neurosis diabetes, pelvic surgery history, etc. (4) Patients with coronary heart disease, serious primary cardiovascular disease, liver disease, kidney disease, hematologic disease, pulmonary disease, or serious disease affecting their survival, such as tumor or AIDS, should not be selected. (5) ALT, AST or BUN exceeding 2 times the upper limit of normal value, or eGFR<45ml/min/1.73m2. (6) Postural hypotension. (7) Non-prostatitis caused by the lower abdomen, perineum, lumbosacral and other painful diseases. (8) Patients with allergic constitution or allergy to test drug composition, and patients with a history of sulfonamide drug allergy. (9) Suspected or had a history of alcohol or drug abuse, or had other diseases that, according to the judgment of the investigator, reduced the possibility of enrollment or complicated enrollment, such as frequent changes in the work environment, which could easily lead to loss of follow-up. (10) Patients receiving CYP3A4 or CYP2D6 potent inhibitors (such as Ketoconazole and paroxetine), other adrenergic blockers and cimetidine. (11) Patients who are participating in clinical trials of other drugs, or have participated in a drug clinical trial within the past one month. (12) Other patients deemed unsuitable for the clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
NIH-CPSI score;

Secondary

MeasureTime frame
urinalysis;Blood routine;Urinary ultrasound;liver function;Routine prostatic fluid;Routine stool + occult blood;renal function;Prostatic fluid culture;Uroflowmetry;ECG;

Countries

China

Contacts

Public ContactGAO ZHAN
gaozhanmd@vip.163.com13717826790

Outcome results

None listed

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