Table 1.

Content of data capture

Research stage	Baseline	Treatment period
Item	0	4 weeks ± 3 days	8 weeks ± 3 days	12 weeks ± 3 days
Visiting no.	V1	V2	V3	V4
Demographic data/baseline
Inclusion/exclusion criteria	√
Informed consent	√
History of disease and treatment	√
Physical examination	√	√	√	√
Complications and concomitant medications	√
Outcome assessments
Lipid profiles	√	√	√	√
Hs-CRP	√	√	√	√
Blood pressure	√	√	√	√
Body weight	√	√	√	√
Bristol Stool Chart	√	√	√	√
TCM symptom form	√	√	√	√
Adipokine profiles	√			√
Intestinal microbiota	√			√
Safety assessment
Blood routine measurements	√			√
Urine routine measurements	√			√
Liver function (ALT, AST)	√			√
Kidney function (BUN, Cr)	√			√
Adverse events	√	√	√	√
Others
Randomization	√
Drug distribution	√	√	√
Drug recycling and counting		√	√	√
Record concomitant medications		√	√	√
Study conclusion				√

√: item need to be done during different period