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

Guiyang Xintian Pharmaceutical

Status and phase: Enrolling; Phase 4

Conditions: Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Treatments: Drug: Tamsulosin; Drug: Ningmitai capsule; Drug: Silodosin Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05551221

TREC2022-17

Details and patient eligibility

About

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.

Full description

Sample size: 312

Enrollment: 312 estimated patients

Sex: Male

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 3 patient groups

Tamsulosin Hydrochloride Capsules combine with Ningmitai Capsules placebo

Active Comparator group

Description:

Patients take tamsulosin hydrochloride capsules (1 tablet each time, once daily) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid.)

Treatment:

Drug: Tamsulosin

Silodosin Capsules combine with Ningmitai Capsules placebo

Experimental group

Description:

Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules placebo (0.38 g/capsule, 4 capsules/time, tid).

Treatment:

Drug: Silodosin Capsules

Silodosin Capsules combine with Ningmitai Capsules

Experimental group

Description:

Patients take Silodosin Capsules ( Qianweitai®, 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner) and Ningmitai capsules (Ningmitai®, 0.38 g/capsule, 4 capsules/time, tid).

Treatment:

Drug: Silodosin Capsules

Drug: Ningmitai capsule