Evidence-Based Complementary and Alternative Medicine / 2017 / Article / Tab 3

Research Article

The Efficacy and Safety of Shen Guo Lao Nian Granule for Common Cold of Qi-Deficiency Syndrome: Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase II Clinical Trial

Table 3

Study schedule for patients. On the 1st day, researchers collect the data of medical and treatment history, efficacy observation, safety assessment, and exclusive observation of patients, as well as randomization, allocation, and drug distribution. On the 4th day (fulfilled for 4 days to the first time of medicine consume), patients take the second visit for physical examination, and researchers record symptoms scores, combined medication, and adverse event (if any). The 6th ± 1 day (fulfilled for 6 days to the first time of medicine consume), patients take the third visit for physical examination and the second safety assessment, and researchers record symptoms scores, combined medication, adverse event (if any), and recycled medicines and pack box, and drug quantity statistics. On the 11th ± 2 day (fulfilled for 11 days to the first time of medicine consume), patients take the fourth visit for physical examination, and researchers record symptoms scores, combined medication, and adverse event (if any).

StageVisit period
TreatmentVisit 1Visit 2Visit 3Visit 4
Day1 day4th day6th ± 1 day11th ± 2 days

Basic medical history recording
Informed consent signing×
General information recording×
Medical and treatment history recording×
Complication and symptoms recording×
Physical examining××××
Combined medication recording×××
Efficacy observation
Symptoms scores recording××××
Safety assessment
Routine blood test××
Routine urine + urinary sediment microscopy××
Liver function test××
Renal function test××
Fasting blood glucose + 2 h postprandial blood glucose××
Electrocardiogram××
Excluding observation
Chest X-ray×
Urine pregnancy test (female)×
Fasting blood glucose + 2 h postprandial blood glucose×
Adverse events observation
Adverse event recording×××
Other works
Randomization and allocation×
Drug distribution×
Medicines and packing box recycling×
Drug quantity statistics×

Article of the Year Award: Outstanding research contributions of 2020, as selected by our Chief Editors. Read the winning articles.