A multicenter, prospective, randomized, double-blind, positive controlled clinical study to evaluate the efficacy and safety of Silodosin Capsules used singly or combined with Ningmitai Capsules in the treatment of subjects with Benign Prostatic Hyperplasia (BPH) complicated with Lower Urinary Tract Symptoms (LUTS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061362

Enrollment

Unknown

Registered

2022-06-22

Start date

2022-07-01

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia (BPH) complicated with Lower Urinary Tract Symptoms (LUTS)

Interventions

Group A:Oral Tamsulosin Hydrochloride Capsules were tested, 1 tablet at a time, 1 time a day. Medication time:12 weeks..Oral Tamsulosin Hydrochloride Capsules were tested, 1 tablet at a time, 1 time a

Gruop B:Oral Silodosin Capsules (Qianweitai ?, 4 mg/capsule), 1 capsule/time, bid, after breakfast and dinner

Oral placebo(Ningmitai Capsules (0.38g/capsule)), 4 capsules/time, tid. Medication time:12 weeks.

Gruop C:Oral Silodosin Capsules (Qianweitai ?, 4 mg/capsule), 1 capsule/time, bid, after breakfast and dinner

Oral Ningmitai Capsules (0.38g/capsule), 4 capsules/time, tid. Medication time:12 weeks.

Eligibility

Sex/Gender

Male

Age

60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. MaleSubjects 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

Exclusion criteria: 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 100ml, or those who may have urinary retention and need catheterization; 7. Subjects who took a receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial; 8. Subjects who take 5a reductase inhibitor or other antiandrogen therapy drugs within half a year before participating in this clinical trial; 9. Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment; 10. Subjects who are complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases; 11. Subjects have significant abnormalities in clinical or laboratory examination indexes of subjects, such as ALT and AST = 1.5 times the upper limit of the reference value, creatinine (Scr) > the upper limit of the reference value, or poor blood glucose control (fasting blood glucose FPG = 7.0 mmol/L); 12. Subjects who are allergic to the drugs or ingredients used in the test definitely; 13. Any other subjects in the opinion of researchers are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
International Prostate Symptom Score ;	—

Secondary

Measure	Time frame
Quality Of Life;Maximum flow rate;Residual urine volume;Prostate Specific Antigen;Prostate volume;	—

Countries

China

Contacts

Public ContactShan Chen

shanchentr@gmail.com+86 13611257388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026