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
Overview
- Phase
- Phase 2
- Intervention
- Fangji Huangqi pill or Fangji Huangqi pill placebo
- Conditions
- Fangji Huangqi Pill
- Sponsor
- Cui xuejun
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- change of the Western Ontario and McMaster university of orthopedic index
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
A randomized, double-blind, placebo-controlled clinical trials (RCT) will be conducted to explore whether the FHP could relieve pain and protect joints. 200 participants suffering from KOA will be enrolled and treated with FHP or placebo for 1 month. The primary outcome measures are the Visual analogue scale (VAS), Western Ontario and McMaster university of orthopedic index (WOMAC), the Lequesne index, and MOS Sleep Scale would be measured from the baseline to 1 month. The second outcome measures would be the six minutes walking test, the Short Form 36-item Health Survey (SF- 36), the X-ray of both knees, and the adverse events from the baseline to 2 weeks, 4 weeks, and 12 weeks' follow-up. In addition, the VAS score, the WOMAC score, the Lequesne index, and AIS Sleep Scale from the baseline to 2 weeks and 12 weeks' follow-up are also the second outcome measures.
Investigators
Cui xuejun
Clinical research base of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Eligibility Criteria
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
Arms & Interventions
Experimental group
Drug: Fangji Huangqi pill 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill and Mobic
Intervention: Fangji Huangqi pill or Fangji Huangqi pill placebo
Placebo group
Drug: Fangji Huangqi pill placebo 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill placebo and Mobic
Intervention: Fangji Huangqi pill or Fangji Huangqi pill placebo
Outcomes
Primary Outcomes
change of the Western Ontario and McMaster university of orthopedic index
Time Frame: at 1 month
change of the visual analogue scale (VAS)
Time Frame: at 1 month
change of the 6 minutes walk test
Time Frame: at 1 month
change of the Lequesne index
Time Frame: at 1 month
Secondary Outcomes
- change score of the Short Form 36-item Health Survey Questionnaire (SF-36)(from baseline to 12 weeks)
- change of the Western Ontario and McMaster university of orthopedic index(from baseline to 12 weeks)
- change of the visual analogue scale (VAS)(from baseline to 12 weeks)
- change of the Lequesne index(from baseline to 12 weeks)
- change of the 6 minutes walk test(from baseline to 12 weeks)