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NCT01535417
A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
Phase 3 trial testing Shinbaro Capsule in Osteoarthritis in 198 participants. Completed in 1 December 2009.
1 December 2009
Quick facts
| Lead sponsor | Green Cross Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 1 May 2009 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 December 2009 |
Drugs / interventions tested
- Shinbaro Capsule — full drug profile →
- Celebrex (celecoxib) — full drug profile →
Conditions studied
- Osteoarthritis — all drugs for Osteoarthritis →
Sponsor
Green Cross Corporation — full company profile →
Who can join
Adults 35 to 80, any sex, with Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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WOMAC change
Time frame: Baseline, 12 weeks
WOMAC change
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01535417
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis
Currently open trials in the same condition.
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- NCT06631638 — EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) · NA · recruiting
- NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting
- NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
Other Green Cross Corporation trials
Trials by the same sponsor.
- NCT01624532 — A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 · Phase 2 · completed
- NCT04555148 — COVIDIG (COVID-19 Hyper-ImmunoGlobulin) · Phase 2 · completed
- NCT04175522 — Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis: · Phase 2 · completed
- NCT03947138 — A Study of GC3107(BCG Vaccine) in Healthy Infants · Phase 3 · completed
- NCT03492710 — Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency · Phase 3 · withdrawn
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 NCT01535417 (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 Green Cross Corporation
- Last refreshed: 14 February 2012
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/NCT01535417.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing