Non-erosive Reflux DiseaseNCT02149914
The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
A study testing Ryodoraku, ANSWatch and UGI endoscopy in people with Non-erosive Reflux Disease and Barrett's Esophagus, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-erosive Reflux Disease, Barrett's Esophagus
- What is being tested?
- Ryodoraku, ANSWatch and UGI endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female
- age of 20-75 years
- patients with GERD who have to receive PPIs for four weeks
Who cannot join
- Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus
- previously underwent the esophagus, stomach or duodenum surgery
- Lactating women or pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Non-erosive Reflux Disease, Barrett's Esophagus
- Being tested
- Ryodoraku, ANSWatch, UGI endoscopy, GerdQ, PPI
- Keywords
- Ryodoraku, Meridian energy, Heart rate variability, Autonomic Nervous System, GERD
- Medical subject headings
- Non-Erosive Reflux Disease, Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RyodorakuDevice
Also called Meridian energy analysis device, M.E.A.D, Skin Response Measurement Device, Me-Professional
Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication
ANSWatchDevice
Also called "Taiwan Scientific" Noninvasive Blood Pressure Meter, Wrist-worn heart rate monitor, TS-0411
ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication
UGI endoscopyDevice
Also called Upper gastrointestinal endoscope, Fujinon EG350N, Fujinon EG590WR
UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication
GerdQOther
Also called Gastroesophageal reflux disease questionnaire
GerdQ to assess the severity of GERD for each patient before and after taking the medication
PPIDrug
Also called Proton Pump Inhibitor, Rabeprazole, Pariet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ryodoraku; Device: ANSWatch; Device: UGI endoscopy; Other: GerdQ; Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastroesophageal reflux disease questionnaire
To assess the severity of GERD
Measured: four weeks
Secondary outcomes (1)
Upper gastrointestinal endoscopy
To assess the grade of reflux esophagitis
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Ling Shen, Taichung Tzu Chi Hospital
- Investigators
- Mei-Ling Shen, M.D, Study chair, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149914
- Sponsor's protocol ID
- REC103-20
- Status last verified
- Nov 2014
- First submitted
- 18 May 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Ryodoraku and HRV After PPI Treatment in GERD Patients
- ClinicalTrials.gov ID
- NCT02149914
- Acronym / sponsor ID
- REC103-20
- Conditions
- Non-erosive Reflux Disease, Barrett's Esophagus
- Keywords
- Ryodoraku, Meridian energy, Heart rate variability, Autonomic Nervous System, GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPI treatment | Experimental | Device: Ryodoraku, Device: ANSWatch, Device: UGI endoscopy, Other: GerdQ, Drug: PPIPatients 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female
- age of 20-75 years
- patients with GERD who have to receive PPIs for four weeks
Key exclusion criteria (3 listed)
- Suffering from peptic ulcer, gallstones, cancer, and Barrett's esophagus
- previously underwent the esophagus, stomach or duodenum surgery
- Lactating women or pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RyodorakuAlso: Meridian energy analysis device, M.E.A.D, Skin Response Measurement Device, Me-ProfessionalRyodoraku to assess the energy of meridian system for each patient before and after taking the medication | Device | PPI treatment |
| ANSWatchAlso: "Taiwan Scientific" Noninvasive Blood Pressure Meter, Wrist-worn heart rate monitor, TS-0411ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication | Device | PPI treatment |
| UGI endoscopyAlso: Upper gastrointestinal endoscope, Fujinon EG350N, Fujinon EG590WRUGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication | Device | PPI treatment |
| GerdQAlso: Gastroesophageal reflux disease questionnaireGerdQ to assess the severity of GERD for each patient before and after taking the medication | Other | PPI treatment |
| PPIAlso: Proton Pump Inhibitor, Rabeprazole, Pariet | Drug | PPI treatment |
Primary outcome
gastroesophageal reflux disease questionnaire
Time frame: four weeks
To assess the severity of GERD
1 secondary outcome
Upper gastrointestinal endoscopy
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Ling Shen, M.D study chair
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ryodoraku, ANSWatch and UGI endoscopy in people with Non-erosive Reflux Disease and Barrett's Esophagus, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastroesophageal reflux disease questionnaire (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.