NCT02149914

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

May 18, 2014

Last Update Submit

November 19, 2014

Conditions

Non-erosive Reflux DiseaseBarrett's Esophagus

Keywords

RyodorakuMeridian energyHeart rate variabilityAutonomic Nervous SystemGERD

Outcome Measures

Primary Outcomes (1)

  • gastroesophageal reflux disease questionnaire

    To assess the severity of GERD

    four weeks

Secondary Outcomes (1)

  • Upper gastrointestinal endoscopy

    four weeks

Study Arms (1)

PPI treatment

EXPERIMENTAL

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: RyodorakuDevice: ANSWatchDevice: UGI endoscopyOther: GerdQDrug: PPI

Interventions

RyodorakuDEVICE

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

Also known as: Meridian energy analysis device, M.E.A.D, Skin Response Measurement Device, Me-Professional, Me-100
PPI treatment
ANSWatchDEVICE

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

Also known as: "Taiwan Scientific" Noninvasive Blood Pressure Meter, Wrist-worn heart rate monitor, TS-0411
PPI treatment
UGI endoscopyDEVICE

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

Also known as: Upper gastrointestinal endoscope, Fujinon EG350N, Fujinon EG590WR
PPI treatment
GerdQOTHER

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

Also known as: Gastroesophageal reflux disease questionnaire
PPI treatment
PPIDRUG
Also known as: Proton Pump Inhibitor, Rabeprazole, Pariet
PPI treatment

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Tzu Chi Hospital

Taichung, Taiwan, 427, Taiwan

Location

MeSH Terms

Conditions

Non-Erosive Reflux DiseaseBarrett EsophagusGastroesophageal Reflux

Interventions

Proton Pump InhibitorsRabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous ConditionsNeoplasms

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mei-Ling Shen, M.D

    Taichung Tzu Chi Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mei-Ling Shen

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 29, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

November 20, 2014

Record last verified: 2014-11

Locations

TW(1)