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Table 4 Measurement items and time points for data collection

From: Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial

Item

Run-in period

(−14 ± 1) day

Baseline period

(−7~0) days

Intervention period

(28 ± 4) days

Basic information

 

 Informed consent

×

 

 Inclusion/exclusion criteria

 

×

 

 Demographic data

×

 

 Randomization

 

×

 

 Record medical history and allergy history

×

 

 Record complication and symptom

×

 Record concomitant medication

×

 Access to the “Doctor Tao” platform

×

 Urine pregnancy test

×

Safety assessment

 

 Vital signs and physical examination

×

×

×

 Blood and urine routine examination

 

×

×

 Liver function (ALT, AST, AP, TBIL, γ-GT)

×

×

 Kidney function (SCr, BUN)

×

×

 Coagulation function (PT, APTT, TT, FIB, INR)

×

×

 Fasting blood glucose

×

×

Efficacy indicators

 

 Stable angina symptom score

 

×

×

 Electrocardiogram

×

×

 Seattle Angina Questionnaire

×

×

 Nitroglycerin consumption

×

×

×

Other works

 

 Drug distribution

×

×

 

 Drug recycling

 

×

×

 Record adverse events and combined medication

×

×

 Compliance judgement

×

×

  1. ALT alanine aminotransferase, AST aspartate aminotransferase, AP alkaline phosphatase, TBIL total bilirubin, γ-GT γ-glutamyl transpeptidase, SCr serumcreatinine, BUN blood urea nitrogen, PT prothrombin time, APTT activated partial thrombolastin time, TT thrombin time, FIB fibrinogen, INR international normalized ratio