Authors
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Xintian Pharmaceutical -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2023
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
Epistemonikos ID: d5ec463d70243c88952e8e6b20ba030610222a27
First added on: Feb 19, 2024