Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks. Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.
Sample size: 312
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
Silodosin is a α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieves the dynamic obstruction of bladder outlet, and improves the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule,1 capsule/time, bid, after breakfast and dinner.
Ningmitai Capsule (Ningmitai®) is Traditional Chinese Medicine which has already used in treatment of urinary system disease (eg. CPPS, BPH) in China for more than twenty years. The instruction of Ningmitai Capsule is 0.38g/capsule, 4 capsule/time, tid.
Tamsulosin is α1A-adrenergic receptor which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGThe Central Hospital Of WUHAN
Wuhan, Hubei, China
NOT_YET_RECRUITINGWuhan No.1 Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGWuxi No.2 People's Hospital
Wuxi, Jiangsu, China
NOT_YET_RECRUITINGInternational Prostate Symptom Score(IPSS)
Changes of IPSS scores at the 12th week of treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Time frame: 12 week
International Prostate Symptom Score(IPSS) total score
Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline scores. The scores of the scale ranged from 0 to 35. The higher the score, the more severe the symptoms are.
Time frame: 1, 2, 4 and 8 weeks
IPSS Stimulus score
IPSS Stimulation Score at 1, 2, 4, 8, 12 weeks (Sum of Question 2, 4, 7) compared with baseline. The scores of the scale ranged from 0 to 15. The higher the score, the more severe the symptoms are.
Time frame: 1, 2, 4 ,8 and 12 weeks
IPSS obstruction score
Changes of IPSS obstruction score (sum of question 1, 3, 5, 6) at 1, 2, 4, 8, 12 weeks after treatment compared with baseline. The scores of the scale ranged from 0 to 20. The higher the score, the more severe the symptoms are.
Time frame: 1, 2, 4 ,8 and 12 weeks
IPSS total score severity
Proportion of patients with IPSS total score severity decreased by at least one grade at 12 weeks. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).
Time frame: 12 week
Quality of life (QoL) score
Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.
Time frame: 4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)
The change of Qmax at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Residual urine volume (PVR)
Changes of PVR at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Prostate specific antigen (PSA)
Changes of PSA at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Prostate volume (PV)
Changes of PV at 12 weeks of treatment compared with baseline.
Time frame: 12 weeks
Patient response rate
Patient response rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% and Qmax increased by ≥ 30% compared with baseline value after treatment.
Time frame: 12 weeks
Proportion of patients with BPH clinical progression
Clinical progress is defined as the first occurrence of one of the following two conditions during the trial: 1. Acute urinary retention (AUR); 2. Clinical diagnosis requires surgical treatment of BPH.
Time frame: 12 weeks
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