Globus
Conditions
Brief 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.
Interventions
DRUGOmeprazole
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).
BEHAVIORALpsychoeducation
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.
DRUGFlupentixol +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)
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 1. Occurrence of the sensation between meals. 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 28 days | Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in quality of life | 28 days | Changes in the scores assessed by the 36-Item Short Form Health Survey questionnaire from baseline to the end of the study. |
Countries
Thailand
Outcome results
None listed