Research stage | Enrolment | Allocation | Intervention | Follow up | |||
---|---|---|---|---|---|---|---|
Visit Number | 1st | 1st | 2nd | 3rd | 4th | 5th | 6th |
Time point (week) | -2-0 | 0 | 6 | 12 ± 5d | 18 ± 5d | 24 ± 5d | 30 ± 5d |
Baseline basic information collected | |||||||
Eligibility screen | × | ||||||
Informed consent | × | ||||||
Demographic information | × | ||||||
Medical and treatment history | × | ||||||
Combined disease | × | × | × | × | × | × | × |
Combined medication | × | × | × | × | × | × | × |
Record of diet and exercise | × | × | × | × | × | × | |
Intervention | |||||||
DGSY group | |||||||
Placebo group | |||||||
Observation indices | |||||||
Vital sign and anthropometrics | × | × | × | × | × | × | × |
Imaging | |||||||
MRI-PDFF | × | ||||||
CAP, LSM | × | × | × | × | × | ||
Liver function | |||||||
ALT, AST, GGT, DBIL, TBIL, IBIL | × | × | × | × | × | × | |
Blood lipid | |||||||
TC, TG, LDL-C, HDL-C | × | × | × | ||||
Blood gluose | |||||||
FBG | × | × | × | ||||
FINS | × | × | × | ||||
HOMA - IR | × | × | × | ||||
Life quality questionnaire | |||||||
SF-36 | × | × | × | ||||
CLDQ-NAFLD | × | × | × | ||||
TCMSSS | × | × | × | ||||
Safety observations | |||||||
Urine pregnancy test | × | ||||||
Blood routine | × | × | × | ||||
Urine routine | × | × | × | ||||
Renal function | × | × | × | ||||
Adverse event | × | × | × | × | × |