This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
Patients should take 4 tablet once and 3 times per day for 3 days.
Patients should take 4 tablet once and 3 times per day for 3 days.
Guang'anmen Hospital
Beijing, Beijing Municipality, China
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
Time frame: baseline,72 hours
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
Refer to the"Guidline for Clinical Study of New Chinese Medicines "
Time frame: 72 hours
Change in C-reactive protein (CRP) from baseline to 72 hours
Units of Measure:mg/L
Time frame: baseline,72 hours
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
Units of Measure:mm/hour
Time frame: baseline,72 hours
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
Time frame: baseline,72 hours
The number of adverse events related to treatment
Time frame: 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.