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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02149914
Enrollment
120
Registered
2014-05-29
Start date
2014-05-31
Completion date
2016-07-31
Last updated
2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-erosive Reflux Disease, Barrett's Esophagus

Keywords

Ryodoraku, Meridian energy, Heart rate variability, Autonomic Nervous System, GERD

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.

Interventions

DEVICERyodoraku

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

DEVICEANSWatch

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

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

OTHERGerdQ

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

DRUGPPI

Sponsors

Taichung Tzu Chi Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
gastroesophageal reflux disease questionnairefour weeksTo assess the severity of GERD

Secondary

MeasureTime frameDescription
Upper gastrointestinal endoscopyfour weeksTo assess the grade of reflux esophagitis

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026