The Effect of Sodium Tanshinone IIA Sulfate and Simvastatin on Elevated Serum Levels of Inflammatory Markers in Patients with Coronary Heart Disease: A Study Protocol for a Randomized Controlled Trial

Table 1

Data Collection Phases and Scheme.

Data collection phase	Phase I: pretreatment 0 day	Phase II: posttreatment 14 days	Phase III: posttreatment 30 days
Inclusion/exclusion criteria	√
Signed informed consent	√
Patient interview
General health	√
Past medical history	√
Signs and symptoms of present illness	√	√	√
Current medications	√	√	√
Physical exam
Tongue and pulse examination	√	√	√
Heart rate and blood pressure	√	√	√
Laboratory tests
Routine blood, urine, and stool (+ occult blood)	√	√
Liver and kidney function	√	√
Blood lipid and glucose	√
Coagulation	√	√
High-sensitivity CRP	√	√	√
Cardiac markers: CK-MB, cTnT, cTnI	√
Electrocardiogram	√	√
Inflammatory markers*	√	√	√
Assessment using TCM and Western medicine	√	√	√
Angina and BSS score	√	√	√
Randomization into treatment groups	√
Overall evaluation
Evaluation of efficacy		√	√
Evaluation of compliance		√	√
Evaluation of safety and side effects		√	√

∗NOTE: blood sample will be stored for analysis at the end of the study. Inflammatory markers include interleukin-6 (IL-6), tumor necrosis factor alpha (TNFα), vascular cell adhesion molecule (VCAM-1), CD40 antigen and CD40 ligand (sCD40L), monocyte chemotactic protein-1 (MCP-1), and matrix metalloproteinase-9 (MMP-9).