NCT03205228

Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors

Treatment Outcomes in Patients With Globus: A Randomized Control Trial of Psychoeducation, Anxiolytics and Proton Pump Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Globus

Interventions

Type	Name	Description
DRUG	Omeprazole	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).
BEHAVIORAL	psychoeducation	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.
DRUG	Flupentixol +Melitracen	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)

Timeline

• Start date: 2017-07-07
• Primary completion: 2018-06-26
• Completion: 2018-07-28
• First posted: 2017-07-02
• Last updated: 2018-08-22

Locations

1 site across 1 country: Thailand