This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
472
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily.
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules Placebo.Oral administration, 1 sack (6g) per time, 3 times daily.
Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
Time frame: 72 hours
Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours.
Time frame: 24/48 hours
The total score of the Traditional Chinese Medicine Syndrome
Change from basline in the total score of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
Time frame: 72 hours
The each item score of the Traditional Chinese Medicine Syndrome
Change from basline in each item of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
Time frame: 72 hours
CRP
Change from baseline in the inflammatory biomarkers CRP and at 72 hours.
Time frame: 72 hours
Rescue medication
The total dose and frequency of rescue medication use within 72 hours of treatment.
Time frame: 72 hours
Time interval
The interval between the first use of emergency medication and the first use of Investigational Product.
Time frame: 72 hours
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