Table 1 Timeline of the trial
Study period | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Screening | Baseline | Treatment | Follow-up | |||||||
Outcomes | Week -1 | Week 0 | Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 8 | Week 10 |
Screening and enrolment | ||||||||||
 Informed consent form | ○ | |||||||||
 Eligibility for study | ○ | |||||||||
 Demographic and clinical details | ○ | |||||||||
 Physical safety examination | ○ | |||||||||
 Randomization | ○ | |||||||||
Intervention | ||||||||||
 TCM granules/placebo + PPI step-down | ○ | ○ | ○ | |||||||
Assessment | ||||||||||
 VAS of heartburn and reflux | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
 Major symptoms scale | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
 Minor symptoms scale | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
 TCM syndromes scale | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 SF-36 | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 PRO for chronic gastrointestinal diseases | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 SAS | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 SDS | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 GERD-HRQL | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 Compliance | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 Cointerventions | ○ | ○ | ○ | ○ | ○ | ○ | ||||
 Adverse events | ○ | ○ | ○ | ○ | ○ | ○ | ||||