benign prostatic hyperplasia (BPH)
Conditions
Interventions
Control group:GUI Yi Tong Long Fang Granule Mimics (1 bag ·bid) + Tamsulosin hydrochloride sustained release capsule (1 capsule ·qnd)
test group:Gui Yi Tong Long Fang Granules (1 sachet-bid) + Tamsulosin Hydrochloride Extended-Release Capsules Analog (1 capsule-qnd)
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Men aged 50 = age = 75 years; (2) Disease duration of more than 3 months; (3) Meet the western medical diagnostic criteria for BPH; (4) International Prostate Symptom Score (IPSS) is moderate (8 points = IPSS = 19 points) and QOL = 3 points; (5) Meet the Chinese medicine diagnostic criteria of BPH kidney deficiency and blood stasis; (6) Those who have not received other treatments before the treatment (those who have received treatment need to stop the medication for at least 2 weeks); (7) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with prostate cancer; or patients with suspected prostate tumors with PSA >10 ng/ml; patients with PSA >4 ng/ml and <10 ng/ml underwent rectal fingerprinting to determine the f-PSA/t-PSA ratio to exclude prostate cancer; (2) Patients with neurogenic bladder bladder neck fibrosis bladder stones bladder cancer urinary tract infections and patients treated with transurethral surgery; (3) Patients with indications for surgical treatment (including renal insufficiency due to obstruction intractable urinary retention recurrent cystitis bladder stones and persistent hematuria); (4) Presence of a history of severe chronic or acute hepatitis; (5) Combined severe hepatic and renal dysfunction defined as AST and/or ALT = 1.5 times the upper limit of normal; creatinine and/or urea nitrogen = normal; (6) Diabetes mellitus with unstable glycemic control fasting blood glucose = 1.5 times the upper limit of normal value or with diabetic complications (diabetic nephropathy peripheral neuropathy); (7) Those with severe central nervous system injury (cerebrovascular disease such as cerebral hemorrhage or ischemia inflammatory brain disease such as encephalitis or meningitis craniocerebral trauma or spinal cord injury) or peripheral nervous system injury or lesion within 6 months; (8) Persons with a history of psychiatric system disorders; (9) Any history of high-risk arrhythmia or arrhythmia confirmed by electrocardiogram (ECG) or ECG results at the screening visit that are clinically significant in the judgment of the investigator as abnormal; (10) Persons with a history of malignant tumor within the last 3 years; (11) History of allergy to the study drug or similar drugs; (12) Presence of postural hypotension or combination of other drugs that may cause postural hypotension such as alpha-blockers; (13) Cases that should be excluded for other reasons in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bladder residual urine volume;prostate volume;Maximum urine flow rate;Chinese Medicine Symptom Score;Quality of life score; | — |
Countries
China
Contacts
Public ContactWang Fu
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed