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NCT06064448
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Phase 4 trial testing Sildenafil in Chronic Prostatitis With Chronic Pelvic Pain Syndrome in 254 participants. Completed in 22 December 2022.
22 December 2022
Quick facts
| Lead sponsor | Xintian Pharmaceutical |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 254 |
| Start date | 19 March 2019 |
| Primary completion | 22 December 2022 |
| Estimated completion | 22 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sildenafil (sildenafil) — full drug profile →
- Ningmitai capsule — full drug profile →
- Ningbitai capsule + sildenafil — full drug profile →
Conditions studied
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome — all drugs for Chronic Prostatitis With Chronic Pelvic Pain Syndrome →
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
Sponsor
Xintian Pharmaceutical — full company profile →
Who can join
Adults 20 to 50, male only, with Chronic Prostatitis With Chronic Pelvic Pain Syndrome or Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Objective: The purpose of this study was to evaluate the clinical efficacy and safety of Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in the treatment of CP/CPPS with erectile dysfunction. Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical study design was adopted. Interventions: ① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks. ② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals for 4 weeks continuously. ③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken continuously for 4 weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The efficacy of combination therapy with Ningmitai capsule and sildenafil in men with chronic prostatitis/chronic pelvic pain syndrome and erectile dysfunction: a prospective, multicenter, randomized controlled trial.
Luo D, Guo J, Chen T, Liu G, et al · · 2025 · cited 3× · PMID 40365426 · DOI 10.1093/sexmed/qfaf024
Verify or expand the search:
- PubMed search for NCT06064448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Currently open trials in the same condition.
- NCT06299683 — Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment · NA · recruiting
- NCT06345014 — The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome · Phase 4 · 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
- NCT05551221 — The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyp · Phase 4 · recruiting
- 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 NCT06064448 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 12 October 2023
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/NCT06064448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing