An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,007
Huazhi Rougan granule
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
Liver-to-spleen CT ratio
Clinical recovery: liver/spleen CT ratio ≥ 1; Obvious effect: liver/spleen CT ratio decreased by 2 grades (severe → mild); Effective: Liver/spleen CT ratio decreased by 1 grade (severe → moderate, or moderate → mild) :+ Ineffective: liver/spleen CT ratio did not change or even increased.
Time frame: 12 weeks
The reduction of traditional Chinese medicine (TCM) syndrome integral
Clinical recovery: syndrome integral decreased ≥ 95%; Obvious Effective:70%≤the reduction of syndrome integral \<95%; Effective :30%≤the reduction of syndrome score \<70%; Ineffective: less than 30% reduction in syndrome integral. note: The reduction of TCM syndrome integral (%) = (Pre-treatment integral - post-treatment integral)/Pre-treatment integralx 100%
Time frame: 12 weeks
the reduction of ALT
Clinical control: Liver enzymology (ALT) returned to normal; + Obvious effect: liver enzyme (ALT) index decreased by ≥50%; Effective: Liver enzyme (ALT) index decreased \<50% but≥ 30%; Ineffective: Liver enzyme (ALT) index decreased \<30%。
Time frame: 12 weeks
the reduction of blood lipid index
blood lipid index including TC、TG、and HDL-C
Time frame: 12 weeks
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