A randomized controlled trial study is conducted to compare treatment efficacy between psycho-education, anxiolytics drug and proton pump inhibitors in participants who met the criteria of globus.
This is a randomized controlled trial in patients with globus. All participants will be allocated into 3 groups (16 subjects/group) : Proton pump inhibitors (miracid®) , anxiolytics drug (Deanxit®) and psycho-education. The study duration is 4 weeks long. Data regarding clinical severity and quality of life of all participants will be collected at the beginning and at the end of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
A capsule of Omeprazole 20 mg \& 1 capsule of placebo will be given in individual subject, once daily for 4 weeks. Both drugs will be presented in the same appearance (white capsule).
Psychoeducation will be given by psychologists at the Day 1 and Day 15 of the study period.One white capsule of placebo will be given once daily for 4 weeks of the study period.
A capsule containing of a tablet of melitracen 10 mg + flupentixol 0.5 mg \& a capsule of placebo will be given once daily, for 4 weeks. Both would be presented in the same appearance (white capsule)
Division of gastroenterology, Department of Medicine, Siriraj hospital
Bangkok Noi, Bangkok, Thailand
Clinical improvement
Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study
Time frame: 28 days
Improvement in quality of life
Changes in the scores assessed by the 36-Item Short Form Health Survey questionnaire from baseline to the end of the study.
Time frame: 28 days
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