To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.
To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients. At the same time, to compare whether there are differences in the uric acid-lowering effects of initiating Dotinurad treatment at different times.And to evaluate the safety and tolerability of the treatment regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
The drug used in the treatment group (from week 1 to 4)and the control group (from week 3 to 4). This is the main intervention factor of the study.
The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.
The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days.
The VAS scores range is from 1 to 10. The higher the score, the more severe the pain.
Time frame: From enrollment to the end of treatment at 1,3,7,14days
Compare the proportions of gout flares at 28 days between two groups
Time frame: From enrollment to the end of treatment at 28 days
Compare the proportions of subjects whose serum uric acid (SUA) levels were ≤ 360 umol/L at 7, 14 and 28 days between two groups
Time frame: From enrollment to the end of treatment at 7, 14 and 28 days
Compare the percentage reduction in SUA from the baseline at 7, 14 and 28 days between two groups
Time frame: From enrollment to the end of treatment at 7, 14 and 28 days
Compare the C-reactive protein (CRP) levels of the two groups at 7 and 14 days
Time frame: From enrollment to the end of treatment at 7,14days
Compare the erythrocyte sedimentation rate (ESR) levels of the two groups at 7 and 14 days
Time frame: From enrollment to the end of treatment at 7,14days
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