The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH

NCT ID: NCT07134907

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2024-07-09

Brief Summary

The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:

1. Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？

2. Dose QWT have other advantages in the improvement of LUTS?

Participants will:

1. Orally take QWT twice daily or tamsulosin once daily for 12 weeks.

2. Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.

Detailed Description

This trial is designed as two stages: screening period, treatment and follow-up period.

Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination.

Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.

Conditions

BPH (Benign Prostatic Hyperplasia)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Qianweitai

Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner).

Group Type: EXPERIMENTAL

Silodosin

Intervention Type: DRUG

Silodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve 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.

Tamsulosin

Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily).

Group Type: ACTIVE_COMPARATOR

Tamsolusin

Intervention Type: DRUG

Tamsulosin is an α1A-adrenergic receptor blocker 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.

Interventions

Silodosin

Silodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve 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.

Intervention Type: DRUG

Tamsolusin

Tamsulosin is an α1A-adrenergic receptor blocker 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.

Intervention Type: DRUG

Other Intervention Names

Qianweitai; Harnal

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Huilun Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shan Chen

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Wuhan Center Hospital

Wuhan, Hubei, China

Wuhan No.1 Hospital

Wuhan, Hubei, China

The Second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Ciivil Aviation General Hospital

Beijing, , China

Countries

China

Other Identifiers

NM-22-A-001-YJ-001

Identifier Type: -

Identifier Source: org_study_id