The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fangji Huangqi Pill, Knee Osteoarthritis

Intervention / Treatment
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* Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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 | Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo<br>* For the treatment group (Fangji Huangqi pill group), patients will administrate Fangji Huangqi pill (4 g) in 200 milliliter hot water as the instruction and take the solution orally twice a day for 1 month. While patients in the placebo group will take Fangji Huangqi pill placebo as the same way as the Fangji Huangqi pill group. Besides that, both groups will administrate Mobic (7.5 mg once a day) in addition.<br>|
| Placebo Comparator: Placebo group<br>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 | Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo<br>* For the treatment group (Fangji Huangqi pill group), patients will administrate Fangji Huangqi pill (4 g) in 200 milliliter hot water as the instruction and take the solution orally twice a day for 1 month. While patients in the placebo group will take Fangji Huangqi pill placebo as the same way as the Fangji Huangqi pill group. Besides that, both groups will administrate Mobic (7.5 mg once a day) in addition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the visual analogue scale (VAS) |  | at 1 month | 
| change of the Western Ontario and McMaster university of orthopedic index |  | at 1 month | 
| change of the Lequesne index |  | at 1 month | 
| change of the 6 minutes walk test |  | at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the visual analogue scale (VAS) |  | from baseline to 2 weeks | 
| change of the visual analogue scale (VAS) |  | from baseline to 12 weeks | 
| change of the Western Ontario and McMaster university of orthopedic index |  | from baseline to 2 weeks | 
| change of the Western Ontario and McMaster university of orthopedic index |  | from baseline to 12 weeks | 
| change of the Lequesne index |  | from baseline to 2 weeks | 
| change of the Lequesne index |  | from baseline to 12 weeks | 
| change of the 6 minutes walk test |  | from baseline to 2 weeks | 
| change of the 6 minutes walk test |  | from baseline to 12 weeks | 
| change score of the Short Form 36-item Health Survey Questionnaire (SF-36) |  | from baseline to 2 weeks | 
| change score of the Short Form 36-item Health Survey Questionnaire (SF-36) |  | from baseline to 4 weeks | 
| change score of the Short Form 36-item Health Survey Questionnaire (SF-36) |  | from baseline to 12 weeks |