Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome

• Status: Completed
• Trial end date: 2022-07-10
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xintian Pharmaceutical
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

1. Aged 18-60 years old male patients;

2. Patients with long-term, repeated pelvic discomfort or pain (NIH-CPSI pain score 4), lasting more than 3 months, may be accompanied by varying degrees of voiding symptoms and sexual dysfunction.

3. Clinical diagnosis: type III prostatitis.

Exclusion Criteria:

1. Use of any antibiotics and 1 receptor blockers in the past two weeks;

2. Suffering from seminal vesiculitis, epididymitis, varicocele and prostate, bladder, urethra and other tumors and other diseases affecting bladder function;

3. Have received TURP, TUIP, internal cystotomy, transurethral hyperthermia/radiofrequency ablation/balloon dilatation, open prostatectomy, or any other prostate surgery and treatment, such as cryotherapy or hyperthermia;

4. Patients with severe cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases and mental illness;

5. Known to be allergic to Ningmitai capsule or some of its components;

6. Involuntary, unable to cooperate with the completion of the study.