Skip to main content

Table 1 Participant timeline

From: Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial

 

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

  1. AE adverse event, LLGD low dose Lingguizhugan decoction, SLGD standard dose Lingguizhugan decoction