benign prostatic hyperplasia
Conditions
Interventions
Large dose group :Take orally, 1 bags (GE Chen capsule 4 capsules) / times, 3 times / day.
Small dose group :Oral administration, 1 bags (GE Chen capsule 2 + geschen capsule simulant 2 tablets) / times, 3 times / day.
Zero dose group :Take orally, 1 bags (GE Chen capsule simulant 4 tablets) / times, 3 times / day.
Sponsors
Beijing's Capital Medical University Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) In line with the diagnosis of benign prostatic hyperplasia (BPH); (2) Traditional Chinese medicine diagnosed as syndrome of turbid and blood stasis; (3) Prostate volume (PV) 30ml; (4) Aged between 50 and 80 (inclusive); (5) The international prostate symptoms score (IPSS) was 7 and 19; (6) Volunteer for this clinical trial, informed consent and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Residual urine volume >150ml,Maximum urinary flow rate >12ml/s; (2) A history of acute urinary retention (AUR) in the last 3 months; (3) History of malignancy in the last 5 years,Prostate biopsies show patients with prostate epithelial neoplasm (PIN) of any grade,Patients who have undergone prostate surgery or other invasive procedures; (4) The TCM diagnosis is deficiency syndrome and cold and humidity syndrome; (5) Combined with other diseases that cause dysuria; (6) A person who has hematuria, or other disease that causes blood to urinate; (7) Serum PSA> upper limit or rectal examination for suspected prostate nodules; (8) a receptor antagonist were used in the last week, M receptor antagonis,Antiandrogenic drugs, Anti - BPH Chinese medicine or plant medicine, Naproxen was used in the last 2 weeks, nilutamide, Cyproterone acetate were used in the laet 3 weeks,Bicalutamide was used in the laet 2 months,alpha-reductase inhibitor was used in the laet 6 months; (9) Poor glycemic control of diabetes(FPG>7.0mmol/L); (10) A person who has fertility requirements or cannot strictly control birth control during the trial; (11) Combined with severe cardiovascular and cerebrovascular diseases, hematological diseases, liver and kidney diseases,ALT,AST> 1.5ULN,Scr>ULN; (12) Allergic constitution or has allergy history to this article ingredient; (13) A patient who is suspected or has a history of drug abuse or dependence;Suffering from mental disorders, hard to work with; (14) Has participated in the drug clinical trial within one month; (15) The investigator considers it inappropriate to participate in a clinical trial, if the investigator believes there is an increased risk to the patient;Any condition that affects the conduct of the study, such as difficulty in adhering to regular visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Symptom (IPSS) score;Diagnosis of benign prostatic hyperplasia (BPH);turbidity and stasis;Prostate volume;Prostate ultrasound;Qmax;Determination of serum prostate specific antigen (PSA);Rectal examination (DRE); | — |
Countries
China
Contacts
Public ContactSun Guoping
Hangzhou FoLian Biotechnology Co., Ltd.
Outcome results
None listed