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

Not Applicable

• Conditions: Barrett's Esophagus; Non-erosive Reflux Disease
• Interventions: Device: Ryodoraku; Device: ANSWatch; Device: UGI endoscopy; Other: GerdQ; Drug: PPI

• Registration Number: NCT02149914
• Lead Sponsor: Taichung Tzu Chi Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-29
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPI treatment	Ryodoraku	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.
PPI treatment	ANSWatch	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.
PPI treatment	UGI endoscopy	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.
PPI treatment	GerdQ	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.
PPI treatment	PPI	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.

Primary Outcome Measures

Name	Time	Method
gastroesophageal reflux disease questionnaire	four weeks	To assess the severity of GERD

Secondary Outcome Measures

Name	Time	Method
Upper gastrointestinal endoscopy	four weeks	To assess the grade of reflux esophagitis

Trial Locations

Locations (1)

Taichung Tzu Chi Hospital; 🇨🇳 Taichung City, Taiwan