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

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02149914
• Other study ID #: REC103-20
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 18, 2014
• Last updated: November 19, 2014
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2014
• Source: Taichung Tzu Chi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Device:
• Ryodoraku
Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication
• ANSWatch
ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication
• UGI endoscopy
UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication

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

Drug:
• PPI

Locations

Country	Name	City	State
Taiwan	Taichung Tzu Chi Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Tzu Chi Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastroesophageal reflux disease questionnaire	To assess the severity of GERD	four weeks	No
Secondary	Upper gastrointestinal endoscopy	To assess the grade of reflux esophagitis	four weeks	No