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Sponsored by: |
ProThera, Inc. |
---|---|
Information provided by: | ProThera, Inc. |
ClinicalTrials.gov Identifier: | NCT00577330 |
Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and 5-lipooxygenase. The study is based on the hypothesis that oral administrration of this botanical will support joint function in people with osteoarthritis of the knee and improve symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Efficacy of Myalgesin™ for the Support of Joint Function in Patients With Osteoarthritis of the Knee — A Prospective Randomized Controlled Study |
Estimated Enrollment: | 110 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
---|---|
Myalgesin: Experimental
Subjects receive Myalgesin twice daily
|
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Twice daily
|
Acetaminophen: Active Comparator
Subjects receive acetaminophen 1000 mg three times a day
|
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Twice daily
|
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Capital Region Progressive Medicine & Longevity Practice ( Stuart I. Erner, MD ) |
Study ID Numbers: | MYG-01-2006, 20052687 |
Study First Received: | December 18, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00577330 |
Health Authority: | United States: Western Institutional Review Board |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |