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Table 1 Schedule of enrollment, intervention, and assessment

From: The efficacy and safety of Sanqi Qushi Granule in patients with idiopathic membranous nephropathy ——protocol of a multicenter, randomized control trial (SQ-AUTUMN)

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

 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

 × 

  1. Abbreviations: M month