Chronic Prostatitis
Conditions
Interventions
Shulie’an Capsules Group:Orally, 2 capsules per dose, 3 times daily
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Meet the western medical diagnostic criteria for chronic prostatitis; (2) 18 years old =11; (4) Having symptoms of chronic prostatitis with a disease duration of >=3 months; (5) Voluntarily participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Comorbidities with other conditions that affect the evaluation of efficacy such as benign prostatic hyperplasia, prostate cancer, bladder or urethral tumors, seminal vesiculitis, epididymitis, urinary tract infections, neurogenic bladder, urethral malformations or strictures, and severe neurosis; (2) Those who have undergone previous prostate or bladder related surgery; (3) Patients with localized pain in the lower abdomen, perineum, lumbosacral and other parts of the body caused by other pathologies as the main manifestation; (4) Patients with combined serious primary diseases of heart, brain, liver, kidney, hematopoietic and other systems and diabetes mellitus, in which blood ALT, AST > 1.5 times the upper limit of normal value, and blood creatinine (Cr) > the upper limit of normal value; (5) Allergic or known hypersensitivity to the large publication and its components; (6) Taking androgen inhibitors (finasteride), antibiotics, a1-blockers (terazosin hydrochloride, doxazosin mesylate, tamsulosin hydrochloride, etc.), and any other specific medications for the treatment of prostatitis (including herbal medicines) within the last 2 weeks; (7) Those who have a clear indication for surgery at the time of screening and who, in the judgment of the investigator, require recent surgical treatment; (8) Those who have planned to have children in the last 6 months; (9) Those with suspected or confirmed tendency to alcohol or drug abuse or dependence; (10) Those who have participated in other clinical trials within 3 months prior to screening; (11) Those who are unable to cooperate, such as psychiatric patients; (12) Other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline after 4 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in NIH-CPSI score from baseline after 2 weeks of treatment.;The changes in each subscale score of the NIH-CPSI from baseline after 4 weeks of treatment.;The changes in the Traditional Chinese Medicine (TCM) Symptom Grading and Quantification Score from baseline after 2 and 4 weeks of treatment.;The disappearance rate of key symptoms (pelvic pain and individual lower urinary tract symptoms) after 4 weeks of treatment.; | — |
Countries
China
Contacts
Public ContactHui Jiang
Peking University First Hospital
Outcome results
None listed