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Efficacy and safety of Qianlieshutong capsule in the treatment of type III prostatitis (TCM syndrome of damp-heat and blood-stasis obstruction): a multicenter, randomized, double-blind, single simulation, positive drug parallel controlled clinical trial

Efficacy and safety of Qianlieshutong capsule in the treatment of type III prostatitis (TCM syndrome of damp-heat and blood-stasis obstruction): a multicenter, randomized, double-blind, single simulation, positive drug parallel controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041642
Enrollment
Unknown
Registered
2021-01-01
Start date
2021-01-20
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

chronic prostatitis

Interventions

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis criterias of type III prostatitis are met; 2. The diagnosis criterias of TCM syndrome of damp-heat and blood-stasis obstruction are met; 3. Aged >= 18 and = 4; 5. Patients sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients have weak waist and knees and are afraid of cold; 2. Patients diagnosed of benign prostatic hyperplasia, acute urinary retention, urethral stricture, epididymitis, seminal vesicle inflammation, severe neurosis, sexually transmitted diseases, bladder tumor, prostate cancer, and urinary male reproductive system tuberculosis; 3. Patients with pain diseases of lower abdomen, perineum, lumbosacral and other parts caused by non prostatitis; 4. Patients with severe cardiovascular, cerebrovascular, liver and kidney, endocrine system, hematopoietic system, mental and nervous system and other primary diseases, liver function ALT and / or AST were 1.5 times higher than the upper limit of normal value, and renal function (CR) was greater than the upper limit of normal value; 5. Suspected or confirmed history of alcohol and drug abuse; 6. Urinary tract infection; 7. Refractory patients treated with a - blockers; 8. Postural hypotension patients; 9. Allergic to the trial drug and its components; 10. Patients who had pelvic surgery within 3 months; 11. Patients who have used drugs or other related treatment for chronic prostatitis in recent 2 weeks; 12. Patients who have participated in other clinical trials in recent 3 months; 13. Patients who have birth planning during the period of medication and within one month after the end of medication; 14. Patients who are considered unsuitable for clinical trials by researchers.

Design outcomes

Primary

MeasureTime frame
NIH-CPSI;

Secondary

MeasureTime frame
Total effective rate of disease;NIH-CPSI;Total effective rate of disease;Pain, urinary tract symptoms and impact on quality of life score;Pain, urinary tract symptoms and impact on quality of life score;CM syndrome;Single symptom of TCM Syndrome;EQ-5D-5L and QALYs;CM-QOL and QALYs;

Countries

China

Contacts

Public ContactWang Jianye

Beijing Hospital

wangjy@bjhmoh.cn+86 10-85136272

Outcome results

None listed

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