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

Launched by XINTIAN PHARMACEUTICAL · Sep 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two different treatments for men with benign prostatic hyperplasia (BPH), which is a condition that causes urinary problems due to an enlarged prostate. The trial is comparing Silodosin Capsules, either alone or combined with Ningmitai Capsules, to a standard treatment called Tamsulosin Hydrochloride. The goal is to see how well these treatments work in improving symptoms like difficulty urinating.

To participate in this trial, men aged 60 to 80 years who have been diagnosed with BPH and have certain urinary symptoms may be eligible. Participants will be randomly assigned to one of three groups for a 12-week treatment period. It's important to note that those with other serious health issues or certain prior treatments may not qualify. Throughout the study, participants will be monitored to ensure their safety and to assess how well the treatments are working. If you or a loved one is interested in this trial, it’s a great opportunity to help improve treatment options for BPH.

Gender

MALE

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.

Trial Officials