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

Overview

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.

Description

Sample size: 312

Eligibility

Inclusion Criteria:

1. Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
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 informed consent 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 < 0.16 times.
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 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.
5. Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
6. Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
7. Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
8. Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods 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 of patients, 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 blood glucose 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.