This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.
TongBi placebo:0.31g,3times a day, oral, for 4 weeks.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The change from Baseline to week 4 in Visual Analog Scale (VAS)score
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
Time frame: 0 weeks,2 weeks,4 weeks
The change from Baseline to week 4 in Western Ontarioand McMaster Universities
WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability
Time frame: 0 weeks,2 weeks and 4 weeks
The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores
SF-36 scores ranges from 0 to 100,it shows the extent of physical function
Time frame: 0 weeks,4 weeks
The number of adverse events
The number of adverse events related to treatment.
Time frame: 4 weeks
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