Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Condition: Chronic Prostatitis
MeSH terms: Prostatitis; Pelvic Pain; Chronic Disease
Study type: Interventional
Phase: Phase 4

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.

      15、Sign the informed consent: Yes

      16、Data collection and Management (A standard data collection and management system include a
      CRF and an electronic data capture:In this study, case report form (CRF) was used to collect
      and manage research data. The sponsor or designated person is responsible for data management
      of the study, including data quality control. The workflow of data management includes data
      entry, data verification and query, medical coding, data audit, database locking, data export
      and transmission, data and data management file archiving, etc.
    

Intervention name(s): Ningmitai Capsule; Tamsulosin Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.; Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
Other intervention name(s): Ningmitai; Tamsulosin
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment