Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
brief 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
detailed description
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. 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
10、Treatment cycle：8 weeks. the trial treatment began on the day of randomization.
11、Visiting nodes：① before treatment (-2 weeks to 0 days), ②4 weeks of treatment (28 ± 10 days), ③ 8 weeks of treatment (56 ± 14 days).
12、Countries of recruitment and research settings: Country:China Province:Anhui Institution(hospital):The first affiliated hospital of Anhui medical university Level of the institution:Tertiary A
13、Recruiting status:Completed Participant age:18 years Participant age:60 years Gender: Male
14、Randomization Procedure:In this study, the research center was used as the stratification factoror random assignment. Subjects were randomly assigned (1:1:1) to Tamsulosin group, NMT group and combination group according to the random allocation table (subject random code) simulated by SAS 9.2 software. Subjects' random numbers cannot be reused by other subjects, whether they are using the study drug or not, or the study is terminated for any reason.
official 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