Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
CompletedPhase 4NCT05890235
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 Sustain…
Study details
- 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
- Conditions
- Interventions
- Drug: Ningmitai Capsule
- Drug: Tamsulosin Hydrochloride
- Sponsor
- Xintian Pharmaceutical
- Start date
- 2018-11-16
- Primary completion
- 2022-07-10
- Sex
- Male
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05890235