Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
1. Clinical trial title：Efficacy and safety of Ningmitai capsule alone or combined with
celecoxib in the treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
(CP/CPPS): A prospective, randomized, double-blind, multicenter clinical study
2. Version number/date：1.1/2023-10-09
3. Principal investigator：Zhou Huiliang
4. Main research units：The First Affiliated Hospital of Fujian Medical University
5. Clinical trial start and end dates：2023/07/01-2025/12/31
6. Objective: To evaluate whether Ningmitai capsule(NMT) alone or combined with Celecoxib
for 6 weeks is more effective than Celecoxib in improving pain symptoms of CP/CPPS
patients.
7. Study type: Interventional study
8. Total sample size:240
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）Negative bacterial in urine before
and after prostate massage; （4）Voluntarily participate in the trial. 10、Exclusion criteria:
1. Utilize any drugs for the treatment of chronic prostatitis in the past 2 weeks;
2. Patients who have received prostate surgery and treatment;
3. Urine WBC ≥ 5/HP, urinary system infection within 12 months, and effective antibiotic
treatment in the early stage;
4. Pelvic pain and voiding dysfunction caused by non-prostatitis factors.
5. Suffering from serious primary cardiovascular disease, liver disease, kidney disease,
hematological disease, lung disease or other serious diseases such as tumors or AIDS;
6. Significant adverse events in clinical or laboratory examination.
7. Allergic to the components of the test drugs or sulfa;
8. Previous active peptic ulcer / bleeding;
9. A birth plan within the past 8 months;
10. Legally disabled patients or psychiatric patients;
11. Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the
possibility of enrollment；
12. Participating in other clinical trials;
13. Considered unsuitable for enrollment by the investigator. 11、Interventions:
（1）Ningmitai group （2）Celecoxib group （3）Combination group