Research Article

A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE)

Table 1

Complete trial schedule for subjects, including preliminary assessment, stage 1, assessment during washout period, stage 2, and post-administration assessment.

StagePreliminary Assessment Stage 1Assessment during Washout Period Stage 2Post-administration Assessment

Protocol ActivitiesDay -26~-1Day 0Day 1Day 2Day 3Days 4~6Day 7Day 8Day 22Day 35Day 36Day 37Days 38~40Day 41Day 42Day 49

Inclusion/Exclusion Decision               

Acquisition of Consent               

Hospitalization   

Administration of Study Drugs        

Medical Examination by Physician

Blood Pressure/Pulse Measurement 

Body Temperature Measurement 

Weight Measurement         

Blood Test 

Urinalysis   

Electrocardiogram