Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial

Table 1 Trial process chart

Period	Run-in period	Treatment period			Follow-up period
Day	−7	0	7	14	30	60	90
Informed consent	×	×
Inclusion or exclusion criteria	×	×
Medical history	×	×
Medical examination	×
Combined disease treatment	×	×	×	×	×	×	×
Outcome measures:
Proportion of patients who have a clinically significant change as defined by Seattle Angina Questionnaire: angina frequency score		×			×	×	×
Symptom questionnaire of traditional Chinese medicine		×	×	×	×	×	×
The other four Seattle Angina Questionnaire scales		×	×	×	×	×	×
Frequency of anginal attack per week	×	×	×	×	×	×	×
Canadian Cardiovascular Society grade		×	×	×	×	×	×
Consumption of short-acting nitrates	×	×	×	×	×	×	×
Electrocardiogram		×	×	×	×	×	×
Serum lipids		×		×
High-sensitivity C-reactive protein		×		×
Platelet aggregation rate		×		×
New-onset major vascular events							×
Overall mortality							×
Incidence of severe haemorrhage							×
Incidence of moderate haemorrhage							×
Adverse and serious adverse events			×	×	×	×	×
Exercise tolerance test (if necessary after 1st interim analysis)		×		×
Profiles of micro-RNA in 60 patients in certain centres		×		×			×
Profiles of mRNA in 60 patients in certain centres		×		×			×

ISSN: 1745-6215