Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Conditions
Interventions
Control Group:Take the oral Ningmitai capsule-matching placebo
Experimental group:Take Ningmitai capsules
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Aged >=18 years and 4; 5.Able to read, understand, and complete the study questionnaires; 6.Willing to participate in this clinical trial, has given informed consent, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have taken a-blockers, antibiotics, PDE5 inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), proton pump inhibitors, H2 receptor antagonists, or any Chinese patent medicines, herbal remedies, antidepressants, or anxiolytics for prostatitis within 2 weeks prior to enrollment; those currently using medications for this condition must discontinue them for at least 2 weeks before participating in this clinical trial. 2.Patients who have previously undergone transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), open prostatectomy, biofeedback therapy, thermotherapy, cryoablation of the prostate, transperineal extracorporeal shock wave therapy, intraprostatic injection, transurethral prostatic perfusion, or any other prostate-related surgical or interventional treatments, as well as those who have undergone bladder neck incision or other urogenital surgeries. 3.Frequent episodes of diarrhea (watery stools), constipation (no bowel movement for >3 days), bloody stools, melena, or rectal bleeding, with symptom intervals =3 days. 4.Suffering from diabetes, ulcerative colitis, Crohn’s disease, or any other infectious disease. 5.Patients with >10 leukocytes/µL in un-centrifuged urine, or >5 leukocytes/high-power field (HP) in urinary sediment, or a positive leukocyte esterase test, or concomitant urinary tract infection. 6.Patients with any other conditions that may cause pelvic pain or voiding dysfunction, including but not limited to benign prostatic hyperplasia, epididymal or testicular disorders, spermatic cord diseases, overactive bladder, ureteral stones, bladder stones, neurogenic bladder, interstitial cystitis, glandular cystitis, sexually transmitted diseases, bladder tumors, prostate cancer, anorectal disorders, lumbar spine diseases, or central and peripheral neuropathies. 7.Patients with confirmed severe primary cardiovascular disease (e.g., myocardial infarction within the past 6 months, unstable angina, severe arrhythmia), hepatic disease (e.g., active viral hepatitis, cirrhosis with Child–Pugh class B or C), renal disease (e.g., chronic renal failure with eGFR 1.5× the upper limit of normal (ULN), serum creatinine (Scr) >ULN, or electrocardiographic findings that are abnormal and clinically meaningful. 9.Individuals with a known hypersensitivity to the investigational drug or any of its components, or those who have previously experienced significant adverse reactions to this product. 10.Patients who do not agree to use medically approved contraceptive measures during the study treatment period and for 3 months after the last dose. 11.Patients who are legally disabled (e.g., blind, deaf, mute, intellectually impaired), or those with psychiatric disorders, or moderate-to-severe depression/anxiety requiring pharmacological treatment. 12.Patients with a suspected or confirmed history of alcohol or drug abuse, or an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbial diversity;Metabolomic analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| NIH-CPSI Score; | — |
Countries
China
Contacts
Public ContactZhuang Xuan
The First Affiliated Hospital of Xiamen University
Outcome results
None listed