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 | × | × |