binign prostatic hyperplasia
Conditions
Sponsors
Department of Urology, Affiliated Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Married middle and old age men, between 40 and 70 years old; 2. Men with diagnosed LUTS based on urological symptoms, including rinary frequency, urinary urgency, dysuresia, nocturia; 3. Men with clinically diagnosed binign prostatic hyperplasia (BPH); 4. I-PSS<=19; 5. At least in the last 6 months, participants have stable relationships; 6. Participants who've been taken a blocker, 5 alpha reductase inhibitorChinese patent drug and herbal medicine for BPH should withdrawal for 2 weeks under the supervision of researchers plus participants' will; 7. Signed informed consent; 8. Participants could understand the requirements of this trial.
Exclusion criteria
Exclusion criteria: 1. I-PSS 20~35, BPH patients with operation indication, or patients with suspected or confirmed prostatic cancer; 2. Patients with diseases could affect micturition, such as neurogenic bladder dysfunction or urethral sticture; 3. Patients with congenital deformity and anatomic abnormality of the genital organ; 4. Patients who have history of operation or traumatic, which affect the evaluation of efficacy of the drug. 5. Patients with diabetes mellitus, severe cardiovascular disease, sexually transmitted disease, malignant tumor, peptic ulcer and hemorrhagic disease; 6.Patients are taking drugs affect function of bladder outlet and sexual; 7. Patients with insufficiency of liver or kidney, AST or ALT more than 1.5 times the upper limit of normal, creatinine more than the upper limit of normal and with clinical significance; 8. Have history of allergic reactions of study drug or similar drugs; 9. Patients with mental diseases, acrasia, alcohol dependence and drug abuse; 10. In three months participated in any other clinical trials, or have birth preparation; 11. Researchers recorgnized anyone who is not suitable to participate in this clinical study of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum flow rate;I-PS; | — |
Secondary
| Measure | Time frame |
|---|---|
| prostate volume;residual urine volume;QoL;MSF-4;IIEF;GA; | — |
Countries
China
Contacts
Public ContactZhangqun Ye
Jiangsu Honghui Pharmaceutical CO.LTD
Outcome results
None listed