Table 5 Participant timeline

Time point

-4W-0day

0day

4W±3day

12W±3day

24W±3day

 Demographic information

×

 Physical examination

×

×

×

×

 Informed consent

×

 Medical history

×

 Past history

×

 Concomitant treatment

×

×

×

×

 Review selection

×

 Allocation

×

 Treatment group

×

×

×

 Control group

×

×

×

 Clinical sign and symptom score

×

×

×

×

 Chinese medicine diagnosis

×

  Kimura-Takemoto classification

×

×

  Biopsy

×

×

 13C or 14C breath test

×

 SF-12

×

×

 Complete blood cell count

×

×

 Liver function

×

×

 Renal function

×

×

 Urinalysis

×

×

 ECG

×

×

 Urine pregnancy test

×

 Adverse events

×

×

×

 Efficacy determination

×

 Drug distribution

×

×

×

 Drug recycling and count

×

×

×

 Patient record card release

×

 Patient record card recycling

×

 Check patient record card and conduct clinical evaluation

×

×

×

 Summary

×