Study phase | ||||||
---|---|---|---|---|---|---|
Screening | Allocation | Intervention | Follow-up | |||
Time point (weeks) | –2 | 0 | 4 | 8 | 12 | 16 |
Enrollment | ||||||
Eligibility | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
Intervention | ||||||
SLGD | X | X | X | |||
LLGD | X | X | X | |||
Placebo | X | X | X | |||
Assessment | ||||||
Demographic indexes | X | X | ||||
HOMA-IR | X | X | X | X | ||
Hepatic function | X | X | X | X | ||
Lipid metabolism | X | X | X | X | ||
Glucose metabolism | X | X | X | X | ||
Inflammation response | X | X | X | X | ||
Liver-kidney echo ratio | X | X | ||||
Body measurements | X | X | X | X | X | |
TCM pattern scale | X | X | X | X | X | |
SF-36 | X | X | X | |||
SAS | X | X | X | |||
SDS | X | X | X | |||
Vital signs | X | X | X | X | X | |
Blood routine test | X | X | X | X | ||
Electrocardiograph | X | X | X | |||
AEs | X | X | X | X | X | |
Biological sample collection | X | X | X | X |