Benign Prostatic Hyperplasia
Conditions
Interventions
Control group:Oral alpha receptor antagonist (according to the dosage specified in the instructions for treating BPH)
Low dose group:Oral administration of Tranilast Capsules (Qu Ke Shen, Yao Da Pharmaceutical) 100mg TID+oral administration of alpha receptor antagonist (according to the dosage specified in the instru
High dose group:Oral administration of Tranilast Capsules (Qu Ke Shen, Yao Da Pharmaceutical) 200mg TID+oral administration of alpha receptor antagonist (according to the dosage specified in the instr
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients with benign prostatic hyperplasia aged 55 to 75 years old; (2) The patient's prostate volume is greater than 40mL; (3) There is urinary obstruction, with an International Prostate Symptom Score (IPSS) greater than or equal to 8 points, and a maximum urinary flow rate of less than 15ml/s (urinary flow rate is not measured in patients with indwelling catheters).
Exclusion criteria
Exclusion criteria: (1) Urinary disorders caused by neurogenic diseases; (2) Acute urinary tract infections have not been effectively controlled; (3) There are factors of lower urinary tract obstruction other than BPH, such as urethral stricture; (4) History of radiation therapy or surgery in the lower urinary tract or pelvic cavity; (5) Have ever suffered from tumor of urinary system, or suspected of suffering from tumor of urinary system (such as bladder cancer cancer, prostate cancer); (6) Current or past liver function abnormalities (exceeding the test reference value limit); (7) Abnormal renal function (exceeding the test reference value limit); (8) Currently taking warfarin; (9) Allergic to tranilast or drug preparations; (10) Suffering from other major diseases (malignant tumors, autoimmune diseases, angina pectoris, heart failure, severe respiratory and digestive diseases, etc.), and not yet clinically cured; (11) Other researchers believe that patients who are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| International prostate symptom score;Quality of life score;International Index of Erectile Function;Blood routine;Biochemical routine; | — |
Countries
China
Contacts
Public ContactYifeng Jing
Shanghai General Hospital
Outcome results
None listed