Single-arm, open, multi-center phase IV clinical trial of Lingze tablet in the treatment of benign prostatic hyperplasia
- Conditions
- Prostatic hyperplasia
- Registration Number
- ITMCTR2000003335
- Lead Sponsor
- The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1. Meet the diagnostic criteria of BPH;
2. Conform to the syndrome differentiation standard of kidney deficiency, blood stasis and dampness syndrome (not required by Western Hospital);
3. Men aged 50-80 years;
4. Sign the informed consent voluntarily.
1. Residual urine volume > 150ml;
2. There are other diseases that cause dysuria, such as neurogenic bladder dysfunction, vesicourethral calculus, bladder neck obstruction, urethral stricture, recurrent urinary infection, urinary incontinence, pelvic radiotherapy, postoperative pelvic surgery, bacterial prostatitis, and patients or blood PSA >4 whose prostate biopsy shows any grade of prostatic intraepithelial tumor (PIN) Ng / ml patients with suspected prostate cancer;
3. Received soft / hard cystoscopy or other urethral instrument operators within 7 days before the study;
4. Patients with gastroduodenal ulcer, acute and chronic gastritis and enteritis;
5. Those who have recently complicated with serious cardiovascular and cerebrovascular diseases, serious liver and kidney damage, severe hypertension, poor control of diabetes, blood system diseases, mental disorders, and a history of alcohol dependence or drug abuse;
6. Those who are allergic to the ingredients in the study drug;
7. According to the judgment of the researcher, it is not suitable to join the clinical trial.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Prostate Symptom (I-PSS) score;Curative effect of TCM Syndrome;
- Secondary Outcome Measures
Name Time Method Quality of life index (QOL) score;Residual urine volume of bladder (PVR);Prostate volume;Efficacy of single symptom;