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

November 19, 2014 updated by: Mei-Ling Shen, Taichung Tzu Chi Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 427
        • Taichung Tzu Chi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
Drug: PPI
Other Names:
  • Rabeprazole
  • Proton Pump Inhibitor
  • Pariet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastroesophageal reflux disease questionnaire
Time Frame: four weeks
To assess the severity of GERD
four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper gastrointestinal endoscopy
Time Frame: four weeks
To assess the grade of reflux esophagitis
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Tzu Chi Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (ESTIMATE)

May 29, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC103-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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