Process/item | Run-in period | Run-in period | Pre-treatment | Treatment period | |||
---|---|---|---|---|---|---|---|
Time point | − 7 day | − 1 day | 0 days | 2 weeks | 4 weeks | 6 weeks | 8 weeks |
Baseline information | |||||||
 Informed consent | √ |  |  |  |  |  |  |
 Eligibility screen |  |  | √ |  |  |  |  |
 Medical history | √ |  |  |  |  |  |  |
 Allocation | √ |  |  |  |  |  |  |
Effectiveness observation | |||||||
 Blood pressure | √ |  | √ | √ | √ | √ | √ |
 24-h blood pressure |  |  | √ |  |  |  | √ |
 Pro-inflammatory/anti-inflammatory cytokines |  |  | √ |  |  |  | √ |
 Improvement in TCM syndrome |  |  | √ | √ | √ | √ | √ |
 Improvement in quality of life |  |  | √ |  |  |  | √ |
 Pharmacogenomic evaluation |  |  | √ |  |  |  | √ |
Safety observation | |||||||
 Physical exam |  | √ |  |  |  |  | √ |
 Blood pressure |  | √ |  |  |  |  | √ |
 Routine blood test |  | √ |  |  |  |  | √ |
 Routine urine test |  | √ |  |  |  |  | √ |
 Liver and kidney function |  | √ |  |  |  |  | √ |
 Adverse event |  |  |  | √ | √ | √ | √ |
Other work | |||||||
 CRF audit |  |  |  |  |  |  | √ |