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:
Participant gender:
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