Benign Prostatic Hyperplasia
Conditions
Interventions
Xianjia Decoction Group:Xian Jia Decoction
Control Group:Xianjia Soup (Chinese herbal content 10%)
Sponsors
Hubei University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Benign Prostatic Hyperplasia (BPH) in Western Medicine: 1) Clinical manifestations: Frequent urination, urgency, increased nocturnal urination, hesitancy, weak or thin urinary stream, difficulty in urination, and even urinary retention or incontinence; 2) Ultrasound indicates prostate enlargement or hyperplasia, with prostate volume (PV) calculated as (anteroposterior diameter × vertical diameter × transverse diameter × 0.52) exceeding 25 mL, or residual urine volume (RUV) in the bladder, with RUV less than 60 mL; 3) Digital rectal examination indicates mild to moderate prostate enlargement, smooth surface, resilient and medium-hard consistency, no nodules, and shallow or absent median groove; 4) Urinary flow rate measurement: When urine volume exceeds 150 mL, the maximum urinary flow rate (Qmax) is less than 15 mL/s. Meeting the first 2 criteria or any 3 of the above can diagnose BPH. 2. Meets the diagnostic criteria for Kidney Deficiency with Blood Stasis Syndrome in Traditional Chinese Medicine: 1) Principal symptoms: Difficulty in urination; sinking and distension in the lower abdomen or perineum; 2) Kidney deficiency symptoms: Weakness in the waist and knees; lack of interest in sexual activity; frequent nocturnal urination; pale tongue, deep or fine-weak pulse; 3) Blood stasis symptoms: Dull complexion; sinking and pain in the lower abdomen or perineum; dark tongue with ecchymosis, white or greasy; stringy, fine, andpulse. Meeting 2 principal symptoms, 1 kidney deficiency symptom, and 1 blood stasis symptom, along with tongue and pulse examination, can identify the syndrome as Kidney Deficiency with Blood Stasis. 3. Age between 50-75 years old, willing to participate in the study, cooperative for examinations and treatment, and has signed the informed consent form. 4. No use of medications related to prostate enlargement within the past month. 5. Patients with good compliance, able to adhere to medication, and attend regular follow-ups.
Exclusion criteria
Exclusion criteria: 1. Patients with Prostate Specific Antigen (PSA) greater than 4 ng/ml, suspected or diagnosed with prostate malignancy. 2. Patients with congenital malformations, urethral stricture, malignant bladder tumors, bladder neck hyperplasia, or neurogenic bladder. 3. Patients with severe abnormalities in liver or kidney function, cardiovascular diseases, or hematological disorders. 4. Patients with recurrent urinary tract infections, acute urinary retention, urinary incontinence, or bladder stones requiring surgical intervention; patients with a history of lower urinary tract surgery. 5. Patients with mental disorders who are unable to cooperate with treatment or examinations. 6. Patients with allergic constitutions or a history of allergies to multiple medications. 7. Patients currently participating in other clinical interventional trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score;Evaluation of Traditional Chinese Medicine Therapeutic Effects; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Quality of Life Rating;Maximum urinary flow rate;Prostate Volume;Residual urine volume in the bladder;International Erectile Function Score; | — |
Countries
China
Contacts
Public ContactCao Jigang
Hubei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed