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

Not Applicable

Completed

• Conditions: BPH (Benign Prostatic Hyperplasia)
• Interventions: Drug: Silodosin; Drug: Tamsolusin

• Registration Number: NCT07134907
• Lead Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study Start: 2022-07-18
• Primary Completion: 2024-07-09
• Study Completion: 2024-07-09
• Status Verified: 2025-08
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qianweitai	Silodosin	Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner).
Tamsulosin	Tamsolusin	Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily).

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score（IPSS）	week 12	Changes of IPSS scores at the 12th week of treatment compared with baseline scores.

Secondary Outcome Measures

Name	Time	Method
International Prostate Symptom Score（IPSS） total score	1, 2, 4 and 8 weeks	Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline
IPSS storage subscore	1, 2, 4 and 8 weeks	Changes of IPSS storage subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
IPSS total score severity	week 12	Proportion of patients with IPSS total score severity decreased by at least one grade at 12 weeks. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).
Quality of life (QoL) score	4, 8 and 12 weeks	Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.
IPSS voiding subscore	1, 2, 4 and 8 weeks	Changes of IPSS voiding subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
Maximum urinary flow rate (Qmax)	week 12	The change of Qmax at the 12th week of treatment compared with baseline.
Residual urine volume (PVR)	week 12	The change of PVR at the 12th week of treatment compared with baseline.
Prostate specific antigen (PSA)	week 12	The change of PSA at the 12th week of treatment compared with baseline.
Prostate volume (PV)	week 12	Changes of PV at 12 the 12th week of treatment compared with baseline.
Responder rate	week 12	Responder rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% and Qmax increased by ≥ 30% compared with baseline value after treatment.
Proportion of patients with BPH clinical progression	week 12	Clinical progress is defined as the first occurrence of one of the following two conditions during the trial: 1. Acute urinary retention (AUR); 2. Clinical diagnosis requires surgical treatment of BPH.

Trial Locations

Locations (6)

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