Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A Prospective, Randomized, Positive Drug-controlled, Multicenter Clinical Study

Detailed Summary

1. Clinical trial title：Efficacy and safety of Ningmitai capsule in patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome：A prospective, randomized, positive drug-controlled, multicenter clinical study 2. Version number/date：1.0 /2018-6-24 3. Principal investigator：Zhang Xiansheng 4. Main research units：The first affiliated hospital of Anhui medical university clinical medical research ethics committee 5. Clinical trial start and end dates：2018-10-1-2022-12-31 6. Objective: To observe whether Ningmitai capsule(NMT) alone or combined with Tamsulosin for 8 weeks is more effective than Tamsulosin in improving symptoms of CP/CPPS . 7. Study type:Interventional study 8. Total sample size:300 9. Inclusion criteria: ① Age: male patients aged 18-60 years; ② Long-term and repeated pelvic discomfort or pain (NIH-CPSI pain score ≥ 4 points), lasting more than 3 months, may be accompanied by different degrees of urination symptoms and sexual dysfunction; ③ Diagnosed as type III prostatitis. Exclusion criteria: * Use any antibiotics and α1 receptor blockers in the past two weeks; ② Suffering from seminal vesiculitis, epididymitis, varicocele, tumors in prostate, bladder and urethra and other diseases affecting bladder function; * Have received transurethral resection of the prostate(TURP), transurethral incision of the prostate (TUIP), bladder neck incision, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy; * Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic diseases and psychosis; ⑤ Patients who are allergic to NMT or some of its components; ⑥ Patients who are involuntarily unable to cooperate with the completion of the test. 10. Interventions: 1\. NMT group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks. Sample size:100 2. Tamsulosin group Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Sample size:100 3.Combination group Oral Ningmitai capsule, 0.38 g/capsule, tid, 4 capsules each time, after meals, for 8 weeks.Tamsulosin Hydrochloride Sustained-release Capsules were orally administered at 0.2 mg/capsule, once daily, 1 capsule each time, for 8 weeks. Sample size:100

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Interventions