2.7. Outcome measures
burping
ADVERSE EVENTS, SECONDARY, BRAIN
The participants completed all the 15 questions in the GSRS questionnaire. Three questions related to feeling bloated, bothered by burping and passing gas or flatus were considered as indigestion subscale. The primary outcome was the change in the cumulative indigestion score from screening to end of the study. Change in the global evaluation of patients’ scores, (a 10-point visual analogue scale where 1 is bad and 10 is good) from screening to the final visit was another primary outcome measure. The scores were assessed at the screening visit (visit 1), visit 3 (day 15), and the final visit (day 30).The secondary outcomes were a change in other subscale scores in the GSRS questionnaire, excluding the indigestion score from screening to the final visit; a change in Bristol stool analysis from screening to the final visit; a change in brain fog questionnaire score from screening to the final visit; and safety by assessing the adverse events. The Bristol stool chart and the Brain Fog questionnaire were assessed at the screening and final visits, while adverse events were monitored throughout the study. As a part of safety, laboratory parameters like hematology, renal function test, liver function test, and urine analysis were performed at screening and the final visit.