Clinical trial NCT03173027: The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Fangji Huangqi Pill
Knee Osteoarthritis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change of the visual analogue scale (VAS)
timeFrame: at 1 month
measure: change of the Western Ontario and McMaster university of orthopedic index
timeFrame: at 1 month
measure: change of the Lequesne index
timeFrame: at 1 month
measure: change of the 6 minutes walk test
timeFrame: at 1 month
Secondary outcomes:
measure: change of the visual analogue scale (VAS)
timeFrame: from baseline to 2 weeks
measure: change of the visual analogue scale (VAS)
timeFrame: from baseline to 12 weeks
measure: change of the Western Ontario and McMaster university of orthopedic index
timeFrame: from baseline to 2 weeks
measure: change of the Western Ontario and McMaster university of orthopedic index
timeFrame: from baseline to 12 weeks
measure: change of the Lequesne index
timeFrame: from baseline to 2 weeks
measure: change of the Lequesne index
timeFrame: from baseline to 12 weeks
measure: change of the 6 minutes walk test
timeFrame: from baseline to 2 weeks
measure: change of the 6 minutes walk test
timeFrame: from baseline to 12 weeks
measure: change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
timeFrame: from baseline to 2 weeks
measure: change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
timeFrame: from baseline to 4 weeks
measure: change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
timeFrame: from baseline to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
References: