Benign prostatic hyperplasia
Conditions
Interventions
Experimental Group:Shuliean Capsule, 2 capsules taken orally three times daily
Control Group:Shuliean Capsule matching placebo, 2 capsules taken orally three times daily
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Male individuals aged 50 to 80 years (inclusive of 50 and 80 years); (2) Meeting the diagnostic criteria for benign prostatic hyperplasia; (3) Treated with a syndrome differentiation based on traditional Chinese medicine as "damp-heat descending syndrome"; (4) International Prostate Symptom Score (IPSS) total score = 12 points; (5) Maximum urine flow rate Qmax 150 ml); (6) Prostate volume (via abdominal ultrasound) > 20 ml; (7) Voluntarily participating in this clinical trial, having given informed consent and signing the informed consent form.
Exclusion criteria
Exclusion criteria: (1) The researchers defined any disease other than benign prostatic hyperplasia that could lead to urinary symptoms or changes in urine flow rate, including but not limited to neurogenic bladder, bladder neck fibrosis, bladder tumor, bladder neck obstruction, pelvic radiotherapy, urinary calculi, urethral stricture, urinary incontinence, phimosis or penile tumor, acute or chronic prostatitis, prostate cancer, acute or chronic urinary tract infection, acute or chronic renal failure, congenital developmental abnormalities of the urinary system, etc.; (2) During the screening process, there were clear surgical indications, and the researchers judged that minimally invasive prostate treatment or surgical treatment (such as prostatectomy) was necessary; (3) There was a history of trauma or surgery in the prostate or pelvic region in the past; (4) There was a history of acute urinary retention within the previous 3 months; (5) Residual urine volume > 150 ml (by abdominal ultrasound) or the researchers judged that catheterization was necessary; (6) Associated with active prostate cancer, clinically suspected prostate cancer, or serum prostate-specific antigen (PSA) > 10.0 ng/mL; or PSA between 4 ng/mL and 10 ng/mL but the ratio of free PSA to total PSA = 0.16, or the research doctor could not clearly rule out prostate malignancy (excluding patients who were suspected of having prostate malignancy but had negative biopsy and stable PSA within 6 months before screening); (7) Complicated with uncontrolled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg), or poorly controlled diabetes (glycated hemoglobin = 8.5%); (8) Complicated with severe primary diseases in the respiratory, liver, kidney and hematopoietic system, endocrine system, etc., and the condition was unstable (such as severe liver or kidney dysfunction: ALT or AST higher than the upper limit of normal value by 1.5 times or renal function Scr exceeding the upper limit of normal reference value); malignant tumors and other serious comorbidities; (9) Had symptoms of symptomatic orthostatic hypotension, recurrent syncope, vertigo, loss of consciousness or syncope history; (10) Had intellectual disability or mental disorder; (11) Suspected or confirmed history of alcohol or drug abuse; (12) Had received the following treatments that affected the evaluation, including but not limited to: 1) Within 2 weeks before the first administration, used a receptor blockers, 5a reductase inhibitors, M receptor antagonists, ß3 receptor agonists, phosphodiesterase-5 (PDE-5) inhibitors and traditional Chinese medicine or herbal medicine for benign prostatic hyperplasia treatment (referring to drugs with effects on benign prostatic hyperplasia in the drug instructions or pharmacological research); 2) Used 5a reductase inhibitors continuously for more than 3 months within the past 6 months or within the drug's 5 half-life period; 3) Using or planning to use drugs that affect bladder function during the study period, such as vasodilator drugs, antihistamine drugs, psychotropic drugs, anti-asthmatic drugs, gastrointestinal antispasmodic analgesic drugs or other drugs affecting urination function. (13) Allergic to the test drugs and their components; (14) The subject or their spouse had a fertility plan during the trial period and within 3 months after stopping the medication; (15) Participated in other interventional clinical trials within the previous 3 months; (16)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Urinary Flow Rate;prostate volume; Residual Urine Volume;Serum Prostate-Specific Antigen ;Micturition frequency;Quality of Life Score;International Index of Erectile Function Score (IIEF-5);Traditional Chinese Medicine (TCM) Syndrome Score;Clinical Global Impression - Improvement Score (CGI-I); | — |
Countries
China
Contacts
Public ContactHui Jiang
Peking University First Hospital
Outcome results
None listed