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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flupentixol + Melitracen & placebo | Experimental | Deanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given |
|
| Proton pump inhibitor & placebo | Active Comparator | Miracid® (Omeprazole) 20 mg/D*4 weeks will be given |
|
| Psychoeducation&placebo | Active Comparator | Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole | Drug | 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). |
| 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 |
| 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 |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monthira Maneerattanaporn, MD., MS. | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of gastroenterology, Department of Medicine, Siriraj hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D000079564 | Globus Sensation |
| ID | Term |
|---|---|
| D003291 | Conversion Disorder |
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D003376 | Counseling |
| D010166 | Palliative Care |
| C000851 | flupentixol, melitracen drug combination |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| psychoeducation | Behavioral | 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. |
|
|
| Flupentixol +Melitracen | Drug | 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) |
|
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D005791 | Patient Care |
| D013812 | Therapeutics |