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Table 2 SPIRIT table: measurement items and content for the schedule of enrollment, interventions, and assessments

From: Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Items Study period
Screening Baseline Treatment period
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8
−1w 0w 4w 8w 12w 16w 20w 24w
Enrolment         
 Inclusion criteria        
 Exclusion criteria        
 Informed consent        
 Randomization        
Interventions         
 WG (n = 24)  
 WJNSG (n = 48/24)  
 JNSG (n = 24)      
General         
 Demographic data        
 Symptoms and signs        
 Past medical history and treatment history        
 Complications and drug combination        
 Physical examination (BP, P, R, T)  
Vital signs         
 TCM symptoms and signs
 Renal function (SUA, Scr, BUN)
 Laboratory index (fasting insulin, TG, TC, HDL, LDL, blood electrolytes)  
 24-h uric acid in urine  
Safety data         
 Routine urinalysis
 Blood routine   
 Liver function (ALT, AST, γ-GT)   
 Electrocardiogram     
 Stool routine     
Other data         
 Causes of withdrawal or dropout  
 Safety evaluation  
 Adverse events  
 Analysis  
  1. BP blood pressure, P pulse, R breathing, T temperature, Scr serum creatinine, BUN blood urea nitrogen, SUA serum uric acid, TG blood triglyceride, TC serum total cholesterol, HDL high-density lipoprotein, LDL low-density lipoprotein. √ n = 48