Knee Osteoarthritis Clinical Trial
Official title:
The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis: a Study Protocol for a Randomized, Controlled Clinical Trial
Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common form of arthritis and the leading cause of disability, loss of function and pain worldwide. Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a Chinese medicine which has been widely used in treating KOA in China for hundreds of years to relieve pain, reduce swelling and protect the affected joints from further degeneration. However, no certain evidence to show the effect of FHP for the management of active KOA.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Meet the diagnostic criteria for knee osteoarthritis (American College of Rheumatology criteria) - Grade 0-3 on the Kellgren-Lawrence grading system - No serious medical history - No known drug allergies - No steroids, glucosamine, chondroitin sulfate, sodium hyaluronate before Fangji Huangqi pill treatment within 1 month Exclusion Criteria: - Combined with other disease such as rheumatoid arthritis, lupus arthritis and et. al - Grade 4 on the Kellgren-Lawrence grading system - Allergy to study drug - Participating in other clinical trial - Unwilling to give informed consent |
Country | Name | City | State |
---|---|---|---|
China | Longhua Hospital, Shanghai University of TCM | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Cui xuejun |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of the visual analogue scale (VAS) | at 1 month | ||
Primary | change of the Western Ontario and McMaster university of orthopedic index | at 1 month | ||
Primary | change of the Lequesne index | at 1 month | ||
Primary | change of the 6 minutes walk test | at 1 month | ||
Secondary | change of the visual analogue scale (VAS) | from baseline to 2 weeks | ||
Secondary | change of the visual analogue scale (VAS) | from baseline to 12 weeks | ||
Secondary | change of the Western Ontario and McMaster university of orthopedic index | from baseline to 2 weeks | ||
Secondary | change of the Western Ontario and McMaster university of orthopedic index | from baseline to 12 weeks | ||
Secondary | change of the Lequesne index | from baseline to 2 weeks | ||
Secondary | change of the Lequesne index | from baseline to 12 weeks | ||
Secondary | change of the 6 minutes walk test | from baseline to 2 weeks | ||
Secondary | change of the 6 minutes walk test | from baseline to 12 weeks | ||
Secondary | change score of the Short Form 36-item Health Survey Questionnaire (SF-36) | from baseline to 2 weeks | ||
Secondary | change score of the Short Form 36-item Health Survey Questionnaire (SF-36) | from baseline to 4 weeks | ||
Secondary | change score of the Short Form 36-item Health Survey Questionnaire (SF-36) | from baseline to 12 weeks |
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