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Table 4 Schedule of enrollment and assessments

From: A double-blinded, placebo-controlled randomized trial evaluating the efficacy and safety of Zhigancao Tang granules for treating HFpEF: study protocol for a randomized controlled trial

Study period

Time point

Enrolment

Allocation

Post-allocation

Follow-up

−1 week

Week 0

Week 4

Week 12

Week 24

Enrolment

 Eligibility screen

×

    

 Informed consent

×

    

 Allocation

 

×

   

Interventions

 Zhigancao Tang granules

 

 Zhigancao Tang granule placebo

 

Outcome assessments

 Cardiac function

 

×

×

×

×

 Echocardiography

 

×

×

×

×

 Lee’s scale

 

×

×

×

×

 MLHFQ

 

×

×

×

×

 6MWT

 

×

×

×

×

 NT-pro BNP, ANP

 

×

×

×

 

 ITSS

 

×

×

×

×

Safety assessments

     

 Blood routine

 

×

 

×

 

 Urine routine

 

×

 

×

 

 Liver and kidney function

 

×

 

×

 

 electrocardiograph

 

×

 

×

 

 AE

 

×

×

×

×

 Compliance assessments

  

×

×

 
  1. AE, adverse events; ANP, atrial natriuretic peptide; ITSS, integral Chinese medicine syndrome score; MLHFQ, Minnesota Living with Heart Failure questionnaire scale; NT-proBNP, N-terminal pro-brain natriuretic peptides