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

Phase 4

Recruiting

• Conditions: chronic prostatitis

• Registration Number: ITMCTR2100004596
• Lead Sponsor: Beijing Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: Not specified

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 <= 50 years;
4. Chronic prostatitis symptom index (NIH CPSI) is more than 10, and pain score was >= 4;
5. Patients sign informed consent voluntarily.

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IH-CPSI;

Secondary Outcome Measures

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