Status:
COMPLETED
Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS
Lead Sponsor:
Xintian Pharmaceutical
Conditions:
Chronic Prostatitis
Eligibility:
MALE
18-60 years
Phase:
PHASE4
Brief 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, randomi...
Detailed Description
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, randomi...
Eligibility Criteria
Inclusion
- Age: male patients aged 18-60 years;
- 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;
- Negative bacterial in urine before and after prostate massage;
- Voluntarily participate in the trial and agree to sign an informed consent form.
Exclusion
- Use any non-steroidal anti-inflammatory drugs，α receptor blockers，antibiotics, PDE5 inhibitors or other traditional Chinese medicines or botanicals for the treatment of prostatitis in the past 2 weeks; those who are using drugs for the treatment of prostatitis need to stop the drug for 2 weeks before the clinical trial;
- Patients who have received prostate surgery and treatment such as TURP, TUIP, open prostatectomy, biofeedback therapy, hyperthermia, ablation, prostate cryotherapy, transperineal extracorporeal shock wave therapy, prostate injection therapy, transurethral prostate perfusion therapy, or bladder surgery such as bladder neck incision;
- Urine WBC ≥ 5 /HP, urinary system infection within 3 months;
- Pelvic pain and voiding dysfunction caused by non-prostatitis factors, such as benign prostatic hyperplasia, diseases of testis, epididymis and spermatic cord, overactive bladder, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumor, prostate cancer, anorectal disease, lumbar disease, central and peripheral neuropathy;
- Suffering from serious primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease or other serious diseases such as tumors or AIDS;
- Significant adverse events in clinical or laboratory examination indicators, such as ALT and AST ≥ 1.5 times the upper limit of reference value, creatinine (SCR) \> the upper limit of reference value;
- Allergic to the components of the test drugs or sulfa;
- Previous active peptic ulcer / bleeding;
- A birth plan within the past 8 months;
- Legally disabled patients (blind, deaf, mute, intellectual disability, etc.), psychiatric patients;
- Suspected or confirmed alcohol or drug abuse, or other conditions that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator, such as frequent changes in the working environment that are likely to cause loss to follow-up;
- Participating in other clinical trials;
- Considered unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT06159114
Start Date
December 19 2023
End Date
January 31 2025
Last Update
August 6 2025
Active Locations (1)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China