The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

Inclusion Criteria:

1. Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatichyperplasia.
2. Has an IPSS score ≥ 8 points at Screening and Baseline.
3. Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
4. Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
5. Subjects who can read, understand, and complete the research questionnaire.
6. Subjects willing to participate voluntarily in this clinical trial, give informedconsent and sign informed consent.

Exclusion Criteria:

1. Subjects with prostate cancer or other malignant tumors.
2. Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16times.
3. Subjects suffered from other diseases causing dysuria, such as bladder neck spasm,urethral stricture, neurogenic bladder dysfunction, etc.
4. Subjects have suffered from acute urinary retention, or complicated with grosshematuria, urinary tract infection, bladder stones, secondary upper urinary tracthydronephrosis, urinary incontinence, renal insufficiency and other Subjects thatresearchers believe meet the surgical indications.
5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation oracute urinary retention catheterization or other invasive procedures.
6. Subjects have residual urine volume (PVR) > 100ml, or those who may have urinaryretention and need catheterization.
7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugsfor treating BPH within two weeks before participating this clinical trial.
8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs withinhalf a year before participating this clinical trial.
9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatmentmethods during treatment.
10. Subjects who Complicated with severe cardiovascular and cerebrovascular diseases,respiratory diseases, blood diseases, liver and kidney diseases.
11. There are significant abnormalities in clinical or laboratory examination indexes ofpatients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value,creatinine (Scr) > 1.5 times of the upper limit of reference value, or poor bloodglucose control (fasting blood glucose FPG ≥ 10 mmol/L).
12. Subjects who are allergic to the drugs or ingredients used in the test definitely.
13. Any otherSubjects in the opinion of researchers is not suitable for inclusion.