Evaluating Silodosin and Ningmitai Capsules for Benign Prostatic Hyperplasia

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia (BPH) Complicated With Lower Urinary Tract Symptoms (LUTS) -A Multicenter, Prospective, Randomized, Double-blind, Positive Controlled Study

This study is testing whether Silodosin alone or with Ningmitai can help older men with Benign Prostatic Hyperplasia feel better and improve their urinary symptoms.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (estimated)
• Ages: 60 Years to 80 Years
• Sex: Male
• Sponsor: Xintian Pharmaceutical (Industry-sponsored)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT05551221 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of Silodosin Capsules, both alone and in combination with Ningmitai Capsules, in treating Benign Prostatic Hyperplasia (BPH) with associated lower urinary tract symptoms. The study is designed as a multicenter, prospective, randomized, double-blind, positive controlled trial involving 312 male participants aged 60 to 80 years. Participants will be assigned to one of three groups receiving different treatment regimens over a 12-week period, comparing the outcomes against Tamsulosin Hydrochloride. The primary focus is on improving urinary symptoms and overall quality of life for patients suffering from BPH.

Who should consider this trial

Good fit: Ideal candidates are male subjects aged 60 to 80 years with a clinical diagnosis of benign prostatic hyperplasia and specific urinary symptom scores.

Not a fit: Patients with prostate cancer, other malignant tumors, or conditions causing dysuria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve urinary symptoms and quality of life for men suffering from BPH.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating BPH, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• The Central Hospital Of WUHAN — Wuhan, Hubei, China (Not_yet_recruiting)
• Wuhan No.1 Hospital — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Wuxi No.2 People's Hospital — Wuxi, Jiangsu, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Peiling Shi

Conditions Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia Silodosin Capsules; Ningmitai Capsule; Silodosin