Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS

Launched by XINTIAN PHARMACEUTICAL · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a treatment called Ningmitai capsule, both on its own and combined with another medication called Celecoxib, for men suffering from Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). The trial aims to find out if these treatments can help relieve pain symptoms better than Celecoxib alone. The study will involve 240 male participants aged 18 to 60 who have been experiencing pelvic pain for over three months, along with possible urinary symptoms and sexual difficulties.

If you or a loved one are interested in participating, it's important to know that you must not have used certain medications for prostatitis in the last two weeks and should not have had any recent prostate surgeries or serious health issues. Participants will be randomly assigned to receive either Ningmitai, Celecoxib, or a combination of both for six weeks. Throughout the trial, you can expect regular check-ins to monitor your health and any changes in your symptoms. This study is currently not recruiting but aims to gather valuable information to improve treatment options for men with chronic pelvic pain.

Gender

MALE

Eligibility criteria

• 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 and agree to sign an informed consent form.
• Exclusion Criteria:
• • 1. 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;
• • 2. 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;
• • 3. Urine WBC ≥ 5 /HP, urinary system infection within 3 months;
• • 4. 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;
• • 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 indicators, such as ALT and AST ≥ 1.5 times the upper limit of reference value, creatinine (SCR) \> the upper limit of reference value;
• • 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 (blind, deaf, mute, intellectual disability, etc.), psychiatric patients;
• • 11. 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;
• • 12. Participating in other clinical trials;
• • 13. Considered unsuitable for enrollment by the investigator.