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

Primary Purpose

Non-erosive Reflux Disease, Barrett's Esophagus

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ryodoraku
ANSWatch
UGI endoscopy
GerdQ
PPI
Sponsored by
Taichung Tzu Chi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Non-erosive Reflux Disease focused on measuring Ryodoraku, Meridian energy, Heart rate variability, Autonomic Nervous System, GERD

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taichung Tzu Chi Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PPI treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

gastroesophageal reflux disease questionnaire
To assess the severity of GERD

Secondary Outcome Measures

Upper gastrointestinal endoscopy
To assess the grade of reflux esophagitis

Full Information

First Posted
May 18, 2014
Last Updated
November 19, 2014
Sponsor
Taichung Tzu Chi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02149914
Brief Title
The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
Official Title
The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Tzu Chi Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease, Barrett's Esophagus
Keywords
Ryodoraku, Meridian energy, Heart rate variability, Autonomic Nervous System, GERD

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PPI treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ryodoraku
Other Intervention Name(s)
Meridian energy analysis device, M.E.A.D, Skin Response Measurement Device, Me-Professional, Me-100
Intervention Description
Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication
Intervention Type
Device
Intervention Name(s)
ANSWatch
Other Intervention Name(s)
"Taiwan Scientific" Noninvasive Blood Pressure Meter, Wrist-worn heart rate monitor, TS-0411
Intervention Description
ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication
Intervention Type
Device
Intervention Name(s)
UGI endoscopy
Other Intervention Name(s)
Upper gastrointestinal endoscope, Fujinon EG350N, Fujinon EG590WR
Intervention Description
UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication
Intervention Type
Other
Intervention Name(s)
GerdQ
Other Intervention Name(s)
Gastroesophageal reflux disease questionnaire
Intervention Description
GerdQ to assess the severity of GERD for each patient before and after taking the medication
Intervention Type
Drug
Intervention Name(s)
PPI
Other Intervention Name(s)
Proton Pump Inhibitor, Rabeprazole, Pariet
Primary Outcome Measure Information:
Title
gastroesophageal reflux disease questionnaire
Description
To assess the severity of GERD
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Upper gastrointestinal endoscopy
Description
To assess the grade of reflux esophagitis
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Ling Shen, M.D
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taichung Tzu Chi Hospital
City
Taichung City
ZIP/Postal Code
427
Country
Taiwan

12. IPD Sharing Statement

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

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