Treatment Outcomes in Patients With Globus: A Randomized Control Trial of Psychoeducation, Anxiolytics and Proton Pump Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Flupentixol + Melitracen & placebo
Deanxit® (Flupentixol + Melitracen) 5 mg/D*4 weeks will be given
干预措施: Flupentixol +Melitracen (Drug)
Proton pump inhibitor & placebo
Miracid® (Omeprazole) 20 mg/D*4 weeks will be given
干预措施: Omeprazole (Drug)
Psychoeducation&placebo
Psychoeducation by psychologists will be advised on Day 1 and Day 14 of the study time frame
干预措施: psychoeducation (Behavioral)
结局指标
主要结局
Clinical improvement
时间窗: 28 days
Change in clinical scores assessed by Glasgow-Edinburgh throat Scale from baseline to the endo of the study
次要结局
- Improvement in quality of life(28 days)