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Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by ProThera, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577330
First Posted: December 20, 2007
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ProThera, Inc.
December 18, 2007
December 20, 2007
December 28, 2007
May 2006
Not Provided
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index [ Time Frame: 90 days ]
Same as current
Complete list of historical versions of study NCT00577330 on ClinicalTrials.gov Archive Site
Lesquesne Algofunctional Index [ Time Frame: 90 days ]
Same as current
Not Provided
Not Provided
 
Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis
The Efficacy of Myalgesin™ for the Support of Joint Function in Patients With Osteoarthritis of the Knee — A Prospective Randomized Controlled Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoarthritis
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Twice daily
  • Experimental: Myalgesin
    Subjects receive Myalgesin twice daily
    Intervention: Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
  • Active Comparator: Acetaminophen
    Subjects receive acetaminophen 1000 mg three times a day
    Intervention: Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
110
January 2008
Not Provided

Inclusion Criteria:

  • Men and women age 50-years or older.
  • Patients with symptomatic osteoarthritis of the knees as defined by the American College of Rheumatology criteria(traditional format).
  • At least moderate pain in the knee (rated at 40 or greater by the subject on a visual analogue scale) for most days during the last month.
  • Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month.
  • Baseline functional capacity class 1 to 3, in which class 1 is complete ability to carry out usual activities without handicap,class 2 is ability to adequately conduct usual activities despite handicap of discomfort or limited mobility of one or more joints,and class 3 is limited ability to carry out usual activities. (American Rheumatism Association functional class)
  • Documented radiographic changes of osteoarthritis on a previous knee radiograph (Kellgren-Lawrence grade of 2 or more).

Exclusion Criteria:

  • Age <50-years.
  • Body mass index (BMI) equal to or greater than 35 kg/m2.
  • Baseline functional class 4 with the subject bedridden or confined to wheelchair, largely or wholly incapacitated and capable of little or no self-care. (American Rheumatism Association functional class)
  • Inflammatory arthritis, gout, pseudogout, or Paget's disease.
  • Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic dystrophy, that may interfere with the assessment of joint symptomatology.
  • Severe bursitis of the knee.
  • History of acute joint trauma within 30 days of study entry.
  • Complete loss of articular cartilage.
  • History of total knee replacement.
  • Intra-articular/intramuscular corticosteroids within 30 days of study entry.
  • Intra-articular hyaluronan and hyalans within 30 days of study entry.
  • History of gastrointestinal bleeding within 1 year of study entry.
  • Active peptic ulcer disease, gastroesophageal reflux disease, or inflammatory bowel disease.
  • Gastrointestinal tract ulceration within 30 days of study entry.
  • Severe renal dysfunction defined as a serum creatinine greater than 2 mg/dL.
  • Clinically significant liver disease including an aspartate aminotransferase or alanine aminotransferase >2 times the upper limit of normal.
  • Unwillingness or inability to abstain from ethanol for the study duration.
  • Significant bleeding disorder.
  • History of gastric or duodenal surgery.
  • Warfarin use.
  • Sensitivity to acetaminophen or to any of the components of Myalgesin™.
  • Pregnancy.
  • Any serious medical, social or psychological condition that, in the opinion of the Principal Investigator, would disqualify a subject from participation.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00577330
MYG-01-2006
20052687
No
Not Provided
Not Provided
Stuart I. Erner, MD, The Capital Region Progressive Medicine & Longevity Practice
ProThera, Inc.
Not Provided
Principal Investigator: Stuart I Erner, MD Private Practice
ProThera, Inc.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP