The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis
- Conditions
- Knee OsteoarthritisFangji Huangqi Pill
- Interventions
- Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo
- Registration Number
- NCT03173027
- Lead Sponsor
- Cui xuejun
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Fangji Huangqi pill or Fangji Huangqi pill placebo 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 Experimental group Fangji Huangqi pill or Fangji Huangqi pill placebo 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
- Primary Outcome Measures
Name Time Method change of the Western Ontario and McMaster university of orthopedic index at 1 month change of the visual analogue scale (VAS) at 1 month change of the 6 minutes walk test at 1 month change of the Lequesne index at 1 month
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Longhua Hospital, Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China