Study Period | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Intervention phase | Follow-up phase | |||||||||||
Time point | 0 | M1 | M2 | M3 | M4 | M5 | M6 | M7 | M8 | M9 | M10 | M11 | M12 |
Enrollment | |||||||||||||
Eligibility screening | × | ||||||||||||
Informed consent | × | ||||||||||||
Randomization | × | ||||||||||||
Interventions | |||||||||||||
Cyclical CTX/glucocorticoids therapy + SQG | × | × | × | × | × | × | × | ||||||
Cyclical CTX/glucocorticoids therapy + placebo | × | × | × | × | × | × | × | ||||||
Assessments | |||||||||||||
Demographic data | × | ||||||||||||
Medical history | × | ||||||||||||
Concomitant medication | × | × | × | × | × | × | × | × | × | × | × | × | × |
Symptoms and signs | × | × | × | × | × | × | × | × | × | × | × | × | × |
Physical examination | × | × | × | × | × | × | × | × | × | × | × | × | × |
Routine blood and urine | × | × | × | × | × | × | × | × | × | × | × | × | × |
24 h urinary total protein | × | × | × | × | × | × | × | × | × | × | × | × | × |
Renal function test | × | × | × | × | × | × | × | × | × | × | × | × | × |
Urine Protein:Creatinine Ratio | × | × | × | × | × | × | × | × | × | × | × | × | × |
Serum anti-PLA2R levels | × | × | × | × | × | ||||||||
Liver function test | × | × | × | × | × | × | × | × | × | × | × | × | × |
Serum albumin | × | × | × | × | × | × | × | × | × | × | × | × | × |
Blood lipid | × | × | × | × | × | × | × | × | × | × | × | × | × |
Blood glucose | × | × | × | × | × | × | × | × | × | × | × | × | × |
Serum potassium | × | × | × | × | × | × | × | × | × | × | × | × | × |
Electrocardiogram | × | × | × | × | × | ||||||||
Chest X-ray | × | × | × | × | × | ||||||||
Dampness Syndrome Scale of Chinese Medicine | × | × | × | × | × | × | × | × | × | × | × | × | × |
Adverse events | × | × | × | × | × | × | × | × | × | × | × | × |