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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Globus

Intervention / Treatment
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* Drug: Omeprazole
* Behavioral: psychoeducation
* Drug: Flupentixol +Melitracen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Symptoms based on the following criteria: Persistent or intermittent nonpainful sensation of a lump or foreign body in the throat with no structural lesion identified on physical examination, laryngoscopy, or endoscopy. Occurrence of the sensation between meals. Absence of dysphagia or odynophagia Exclusion Criteria: Subjects with psychological disease Significant heart disease and/or arrhythmia Proton Pump inhibitors and/or Histamine 2 Receptor Antagonist use within 2 weeks before randomization Mono-amine Oxidase inhibitors or Selective Serotonin Reuptake Inhibitor or Tricyclic antidepressant use within 2 weeks before randomization History of drug allergy that use in research Pregnancy or breast feeding Decline to participate in study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flupentixol + Melitracen & placebo<br>Deanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given | Drug: Flupentixol +Melitracen<br>* 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)<br>* Other names: Deanxit®;|
| Active Comparator: Proton pump inhibitor & placebo<br>Miracid® (Omeprazole) 20 mg/D*4 weeks will be given | Drug: Omeprazole<br>* 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).<br>* Other names: Miracid®;|
| Active Comparator: Psychoeducation&placebo<br>Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame | Behavioral: psychoeducation<br>* 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.<br>* Other names: advice for symptoms management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 days |