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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by ProThera, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ProThera, Inc.
ClinicalTrials.gov Identifier:
NCT00577330
First received: December 18, 2007
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Myalgesin™ for the Support of Joint Function in Patients With Osteoarthritis of the Knee — A Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by ProThera, Inc.:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lesquesne Algofunctional Index [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: May 2006
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: Myalgesin
Subjects receive Myalgesin twice daily
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Twice daily
Active Comparator: Acetaminophen
Subjects receive acetaminophen 1000 mg three times a day
Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
Twice daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577330

Locations
United States, New York
Stuart I. Erner, MD
Albany, New York, United States, 12203
Sponsors and Collaborators
ProThera, Inc.
Investigators
Principal Investigator: Stuart I Erner, MD Private Practice
  More Information

No publications provided

Responsible Party: Stuart I. Erner, MD, The Capital Region Progressive Medicine & Longevity Practice
ClinicalTrials.gov Identifier: NCT00577330     History of Changes
Other Study ID Numbers: MYG-01-2006, 20052687
Study First Received: December 18, 2007
Last Updated: December 19, 2007
Health Authority: United States: Western Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014