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临床试验/NCT02149914
NCT02149914Unknown不适用

The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients

Taichung Tzu Chi Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
gastroesophageal reflux disease questionnaire

研究概览

简要总结

Gastroesophageal reflux disease(GERD) mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. Proton pump inhibitors (PPI) can effectively block gastric acid secretion but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. The aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.

详细描述

Gastroesophageal reflux disease(GERD) is a common disease, mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, chest pain and globus hystericus. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. Proton pump inhibitors (PPI) can effectively block gastric acid secretion and promote the repair of esophagus, but the drug reactions and the degree of improvement in symptoms are sometimes unpredictable. Recently there are many instruments used to analyze personal physical status. Meridian energy analysis device ( Ryodoraku ) is used to assess the energy of meridian system by analysis of resistance of the skin surface, as well as the wrist-worn heart rate monitor (ANSWatch) used to assess the autonomic nervous system by analysis of heart rate variability. Therefore, the aim of this study is to investigate the association between the clinical efficacy of PPI in patients with GERD and the personal physical status by Ryodoraku and ANSWatch.

Investigators will recruit 120 patients with GERD in clinic who have to receive PPIs for four weeks and assess each volunteer before and after taking the medication. Assessment methods : 1. ANSWatch to assess the autonomic nervous system, 2. Ryodoraku to assess the energy of meridian system, 3. Upper gastrointestinal endoscopy to assess the grade of reflux esophagitis, 4. gastroesophageal reflux disease questionnaire to assess the severity of GERD. Investigators analysed and compared the database from the assessments between before and after taking the medication.

Investigators anticipate to substantiate that the changes of Ryodoraku and ANSWatch are good predictors for the clinical efficacy of PPI in patients with GERD.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female
  • age of 20-75 years
  • patients with GERD who have to receive PPIs for four weeks

排除标准

  • Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus
  • previously underwent the esophagus, stomach or duodenum surgery
  • Lactating women or pregnant women

研究组 & 干预措施

PPI treatment

Experimental

Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks.

干预措施: Ryodoraku (Device)

PPI treatment

Experimental

Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks.

干预措施: ANSWatch (Device)

PPI treatment

Experimental

Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks.

干预措施: UGI endoscopy (Device)

PPI treatment

Experimental

Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks.

干预措施: GerdQ (Other)

PPI treatment

Experimental

Patients with GERD would be assessed by ANSWatch. Ryodoraku, UGI endoscopy, and GerdQ before taking PPIs and after taking PPI 20mg tablet by mouth everyday for 4 weeks.

干预措施: PPI (Drug)

结局指标

主要结局

gastroesophageal reflux disease questionnaire

时间窗: four weeks

To assess the severity of GERD

次要结局

  • Upper gastrointestinal endoscopy(four weeks)

研究者

发起方
Taichung Tzu Chi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mei-Ling Shen

Mei-Ling Shen

Taichung Tzu Chi Hospital

研究点 (1)

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