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

• Sponsor: Taichung Tzu Chi Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02149914
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-erosive Reflux Disease; Barrett's Esophagus	Device: Ryodoraku; Device: ANSWatch; Device: UGI endoscopy; Other: GerdQ; Drug: PPI	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
• Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Jul 1, 2016
• Anticipated Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: PPI treatment 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.

Device: Ryodoraku; Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication; Other Names: Meridian energy analysis device M.E.A.D Skin Response Measurement Device Me-Professional Me-100 ; Device: ANSWatch; ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication; Other Names: "Taiwan Scientific" Noninvasive Blood Pressure Meter Wrist-worn heart rate monitor TS-0411 ; Device: UGI endoscopy; UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication; Other Names: Upper gastrointestinal endoscope Fujinon EG350N Fujinon EG590WR ; Other: GerdQ; GerdQ to assess the severity of GERD for each patient before and after taking the medication; Other Names: Gastroesophageal reflux disease questionnaire ; Drug: PPI; Other Names: Proton Pump Inhibitor Rabeprazole Pariet

Outcome Measures

Primary Outcome Measures

1. gastroesophageal reflux disease questionnaire [four weeks]

   To assess the severity of GERD

Secondary Outcome Measures

1. Upper gastrointestinal endoscopy [four weeks]

   To assess the grade of reflux esophagitis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Tzu Chi Hospital	Taichung City		Taiwan	427

Sponsors and Collaborators

• Taichung Tzu Chi Hospital

Investigators

• Study Chair: Mei-Ling Shen, M.D, Taichung Tzu Chi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mei-Ling Shen, Mei-Ling Shen, Taichung Tzu Chi Hospital
• ClinicalTrials.gov Identifier: NCT02149914
• Other Study ID Numbers: REC103-20
• First Posted: May 29, 2014
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Mei-Ling Shen, Mei-Ling Shen, Taichung Tzu Chi Hospital: Ryodoraku; Meridian energy; Heart rate variability; Autonomic Nervous System; GERD
• Additional relevant MeSH terms: Barrett Esophagus; Rabeprazole; Proton Pump Inhibitors

Study Results

No Results Posted as of Nov 20, 2014