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A prospective double-blind single-simulation randomized controlled clinical study of Silodosin capsule combined with Ningmitai Capsule in the treatment of benign prostatic hyperplasia

A prospective double-blind single-simulation randomized controlled clinical study of Silodosin capsule combined with Ningmitai Capsule in the treatment of benign prostatic hyperplasia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060060
Enrollment
Unknown
Registered
2022-05-16
Start date
2022-05-06
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

benign prostatic hyperplasia

Interventions

Experimental group:Silodosin capsule+Ningmitai capsule
Control group:Silodosin capsule+Ningmitai capsule mimetics

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the diagnostic criteria of Chinese Guidelines for Diagnosis and Treatment of Urology and Andrology Diseases (2019 edition); 2. The international prostate Symptom score was moderate to severe (12<=IPSS < 25); 3. In line with the diagnosis of damp-heat accumulation or damp-heat stasis type benign prostatic hyperplasia according to the Chinese Association of Integrated Traditional and Western Medicine Diagnosis and Treatment Guidelines for Benign Prostatic Hyperplasia (Trial version); 4. Aged between 50 and 79 years; 5. The subjects are informed and sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Dysuria caused by calculi, urethral malformation, prostate cancer and other factors; 2. Allergic to known drugs; 3. Urinary system infection; 4. Liver and kidney insufficiency; 5. Used Chinese and Western drugs related to the treatment of benign prostatic hyperplasia, including a-blockers, including doxazosin, terrazosin and Tamsulosin, etc., within 2 weeks prior to inclusion; 5a reductase inhibitors (5-ARIs), including finasteride and dutastamide; M receptor antagonists, including tolterodine, oxybutynin and solinaxine; Phosphodiesterase 5 inhibitors (PDE-5Is), including sildenafil, tadanafil and Avanafil; ß3 agonists, including Mirabelon, etc.; Plant preparations, such as sawn palm fruit extract, etc.; 6. Patients who have received urethral dilatation, prostate surgery or microwave treatment within half a year; 7. Patients taking potent cytochrome P4503A4 inhibitors (such as ketoconazole, clarithromycin, itraconazole, Ritonavir); 8. Workers engaged in high-altitude operations, driving, etc.; 9. The researchers think it is not suitable to be included in the group.

Design outcomes

Primary

MeasureTime frame
International Prostate Symptom Score;Maximum urine flow rate;

Secondary

MeasureTime frame
Residual urine volume;Prostate volume;Quality of life;

Countries

China

Contacts

Public ContactGuo Jun

Xiyuan Hospital of China Academy of Chinese Medical Sciences

guojun1126@126.com+86 10 62835134

Outcome results

None listed

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