Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294125
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2006-02-16
Brief Title:
Flavocoxid A Plant-Derived Therapy for the Treatment of Knee Osteoarthritis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Flavocoxid A Medical Food Therapy for Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nonsteroidal anti-inflammatory drugs NSAIDs are commonly prescribed to treat arthritis The purpose of this study is to test the effectiveness of flavocoxid a plant-derived compound for the treatment of knee osteoarthritis OA in adults
Study hypotheses 1 Flavocoxid has an acceptable safety and tolerability profile as determined by the Generally Regarded as Safe GRAS profile in patients with OA compared to identical placebo 2 Flavocoxid will be more effective as a therapy for OA compared to identical placebo
Study hypotheses 1 Flavocoxid has an acceptable safety and tolerability profile as determined by the Generally Regarded as Safe GRAS profile in patients with OA compared to identical placebo 2 Flavocoxid will be more effective as a therapy for OA compared to identical placebo
Detailed Description:
OA is a leading chronic disease in older adults and is characterized by degeneration of articular cartilage of the joints in hands spine knees and hips In joints tissue injury and pain are caused by the conversion of arachidonic acid to such inflammatory compounds as cyclooxygenases-1 and -2 COX-1 and -2 and 5-lipoxygenase 5-LO Conventional NSAIDs inhibit COX-1 and -2 but have little or no effect on 5-LO NSAIDs provide relief from the pain of OA however NSAIDS are also associated with significant side effects including gastrointestinal bleeding venous thrombosis and nephrotoxicity Novel alternative therapies with increased safety and efficacy with fewer or no side effects are desirable plant-derived substances might be useful alternatives to NSAIDs Flavocoxid a botanical extract derived from two plants Scutellaria baicalensis and Acacia catechu has been shown to inhibit COX-1 and -2 as well as 5-LO The purpose of this study is to evaluate the safety and efficacy of flavocoxid in relieving the symptoms of knee OA in adults
This study will last 12 weeks Participants will be randomly assigned to one of two groups Group 1 participants will receive daily flavocoxid Group 2 participants will receive placebo There will be 5 study visits study entry and Weeks 2 4 8 and 12 Joint pain tenderness and swelling will be assessed at each study visit A 30-foot timed walking test will also be performed at all visits A physical exam and blood collection will occur at study entry and Week 12 Other study assessments will include safety monitoring patientphysician global disease ratings quality of life measures depression and anxiety ratings and measures of efficacy as determined by the Western Ontario and McMaster WOMAC OA index
This study will last 12 weeks Participants will be randomly assigned to one of two groups Group 1 participants will receive daily flavocoxid Group 2 participants will receive placebo There will be 5 study visits study entry and Weeks 2 4 8 and 12 Joint pain tenderness and swelling will be assessed at each study visit A 30-foot timed walking test will also be performed at all visits A physical exam and blood collection will occur at study entry and Week 12 Other study assessments will include safety monitoring patientphysician global disease ratings quality of life measures depression and anxiety ratings and measures of efficacy as determined by the Western Ontario and McMaster WOMAC OA index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R41AR051232-01A1 | NIH | None | httpsreporternihgovquickSearch1R41AR051232-01A1 |
| R41AR051232 | NIH | None | None |