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Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS
Sponsor: Xintian Pharmaceutical
Summary
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 Principal investigator:Zhou Huiliang Main research units:The First Affiliated Hospital of Fujian Medical University Clinical trial start and end dates:2023/07/01-2025/12/31 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. Study type: Interventional study Total sample size:240 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. 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. Interventions: 1. Ningmitai group 2. Celecoxib group 3. Combination group
Official 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
Key Details
Gender
MALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2023-12-19
Completion Date
2025-01-31
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Ningmitai capsule
Ningmitai capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
Celecoxib capsule
Celecoxib is one of NSAIDs recommended by the CUA Prostatitis Guidelines for alleviating pain symptoms in CP/CPPS patients. The instruction of Celecoxib capsule is 1 capsule at a time, 1 time a day.
Ningmitai placebo
Ningmitai placebo, a look-alike substance that contains no active drug, similar to Ningmitai capsule in color, smell, taste, shape, texture and other characteristics, 0.38g/ capsule.
Celecoxib placebo
Celecoxib placebo, a look-alike substance that contains no active drug, similar to Celecoxib capsule in color, smell, taste, shape, texture and other characteristics, 0.2g/ capsule.
Locations (1)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China