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NCT05551221: NQTIPS
The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia
Phase 4 trial testing Silodosin Capsules in Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms in 312 participants. Currently enrolling.
31 December 2023
Quick facts
| Lead sponsor | Xintian Pharmaceutical |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 18 July 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2026 |
| Sites | 8 locations across China |
Drugs / interventions tested
- Silodosin Capsules — full drug profile →
- Ningmitai capsule — full drug profile →
- Tamsulosin (tamsulosin) — full drug profile →
Conditions studied
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms — all drugs for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms →
Sponsor
Xintian Pharmaceutical — full company profile →
Who can join
Adults 60 to 80, male only, with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks. Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05551221
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Currently open trials in the same condition.
- NCT07416227 — Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperp · NA · recruiting
Other Xintian Pharmaceutical trials
Trials by the same sponsor.
- NCT06423235 — Efficacy and Safety of Prunella Oral Liquid in the Treatment of Thyroid Nodules · Phase 4 · recruiting
- NCT06159114 — Efficacy and Safety of Ningmitai Capsule Alone or Combined With Celecoxib in the Treatment of CP/CPPS · Phase 4 · completed
- NCT06064448 — Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction · Phase 4 · completed
- NCT05890235 — Efficacy and Safety of Ningmitai Capsule in Patients With Chronic Prostatitis/Chronic Pelvic Pain Syndrome · Phase 4 · completed
- NCT06105827 — Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05551221 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xintian Pharmaceutical
- Last refreshed: 23 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05551221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing