The goal of this study is to "To compare the efficacy and safety of Acotiamide versus Itopride in patient with post prandial distress syndrome type of functional dyspepsia"
Investigator is aiming to conduct an Open-label, comparative randomized controlled, parallel, two-arms, multi-center study. Primary Outcomes: • Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale (LPDS) in 8 weeks from the baseline Secondary Outcomes: * Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale (LPDS) * Difference between both groups in quality of life by using short form Nepean Dyspepsia Index (SF-NDI) from baseline * Frequency of adverse events, serious adverse events and tolerability in both groups
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
152
Both these drugs are used for the management of PDS type of FD
Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks
Overall treatment effect will be assessed using the Leeds Postprandial Distress Scale, with change in total score from baseline before initiation of treatment end of treatment. The decreased score representing the treatment response.
Time frame: 8 weeks
Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale
All the symptoms of PDDS will be assessed by using the Leeds Postprandial Distress Scale (LPDS), with change in total score from baseline before treatment initiation to end of treatment going downwards representing the treatment response.
Time frame: 8 weeks
Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale
Quality of life will be assessed using the Nepean Dyspepsia Index, defined as the change in total score from baseline to the end of the treatment with lower scores indicating improvement
Time frame: 8 weeks
Frequency of adverse events, serious adverse events and tolerability in both groups
Frequency of adverse events will be assessed through a patient diary maintained throughout the study, with entries reviewed at each visit
Time frame: 8 weeks
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