MedDataX Logo

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

NCT ID: NCT02149914

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-erosive Reflux Disease Barrett's Esophagus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Ryodoraku

Intervention Type DEVICE

Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication

ANSWatch

Intervention Type DEVICE

ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication

UGI endoscopy

Intervention Type DEVICE

UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication

GerdQ

Intervention Type OTHER

GerdQ to assess the severity of GERD for each patient before and after taking the medication

PPI

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ryodoraku

Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication

Intervention Type DEVICE

ANSWatch

ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication

Intervention Type DEVICE

UGI endoscopy

UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication

Intervention Type DEVICE

GerdQ

GerdQ to assess the severity of GERD for each patient before and after taking the medication

Intervention Type OTHER

PPI

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Meridian energy analysis device M.E.A.D Skin Response Measurement Device Me-Professional Me-100 "Taiwan Scientific" Noninvasive Blood Pressure Meter Wrist-worn heart rate monitor TS-0411 Upper gastrointestinal endoscope Fujinon EG350N Fujinon EG590WR Gastroesophageal reflux disease questionnaire Proton Pump Inhibitor Rabeprazole Pariet

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taichung Tzu Chi Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mei-Ling Shen

Mei-Ling Shen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mei-Ling Shen, M.D

Role: STUDY_CHAIR

Taichung Tzu Chi Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taichung Tzu Chi Hospital

Taichung, Taiwan, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC103-20

Identifier Type: -

Identifier Source: org_study_id