Evidence-Based Complementary and Alternative Medicine

Research Article

A Single-Central, Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial Protocol: A Clinical Effect Evaluation Study on the TCM Comprehensive Intervention Program for Chronic Heart Failure

Table1

Schedule of intervention and assessments.
Study Period
 EnrolmentAllocationAfter allocation
Intervention phase 1WashoutIntervention phase 2Follow-up
Time pointWk 1Wk 0Wk 1Wk 2Wk 3Wk 4Wk 5Wk 6Wk 7Wk 8Wk 9Wk 106 mo12 mo
Enrolment              
 Eligibility screen×             
 Informed consent×             
 Randomization ×            
Interventions              
 Group A    
 Group B    
AssessmentsPrimary outcome              
 NYHA classification ×   × ×   ×  
Secondary outcomes              
 Echocardiogram ×   × ×   ×  
 NT-proBNP ×   × ×   ×  
 CHFQLS ×   × ×   ×  
 TCM syndrome score ×   × ×   ×  
 Symptom score ×   × ×   ×  
 Sign score ×   × ×   ×  
 6MWT ×   × ×   ×  
 PSQI ×   × ×   ×  
 MoCA ×   × ×   ×  
 MACEs ×   × ×   ×××
 Metabolomics ×   ×        
Safety outcomes              
 Liver and kidney function ×   × ×   ×  
 ARs     × ×   ×  
Schedule of enrollment, intervention, and assessment for the MIRACLE trial was according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [21]. Wk, week; mo, month.