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.
Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
Has an IPSS score ≥ 8 points at Screening and Baseline.
Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
Subjects with prostate cancer or other malignant tumors.
Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.