Gastroesophageal Reflux DiseaseNCT02255071
The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
A study testing Acupressure wristband in people with Gastroesophageal Reflux Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Acupressure wristband
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Dec 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female
- Age of 20-60 years
- Suffered from heartburn with or without acid regurgitation
Who cannot join
- Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
- previously underwent the esophagus, stomach or duodenum surgery
- Lactating women or pregnant women
- patients with severe cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD.
Read the detailed description
In recent years, there is an increasing trend in the number of patients with GERD. GERD 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, and chest pain. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. However, the poor response to medicine was still noticed in patients with non-erosive reflux disease. And long-term use of medicine will result in many side effects including infectious, abdominal pain, diarrhea and osteoporosis. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD. 64 patients with GERD were randomly divided into two groups：the acupressure and control. In the acupressure group, in addition to receiving standard treatment, patients will band a hand ring over Neiguan (P6 point) and acupressure for seven days. In the control group, in addition to receiving standard treatment, patients will band a hand ring but no acupressure for seven days. Data was collected by self-recorded symptoms before and after the intervention, according to the Reflux disease questionnaire(RDQ) and the World Health Organization Quality of Life Questionnaire Taiwan condensed version. Data was analyzed by Student's t-tests, Paired Student's t-test, Chi-square, and Fisher exact tests for quantitative and qualitative variables. We anticipate the treatment of Neiguan (P6 point) acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of life.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Acupressure wristband, Sham wristband
- Keywords
- GERD, Neiguan, Acupressure, P6
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure wristbandDevice
A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
Sham wristbandDevice
A wristband over wrist but no acupressure for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days. Receives: Device: Acupressure wristband |
| Sham-Acupressure | Sham comparator | Patients will band a sham wristband over wrist but no acupressure for seven days. Receives: Device: Sham wristband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux disease questionnaire(RDQ)
RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.
Measured: 7 days
Secondary outcomes (1)
World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Ti Hsu, MD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255071
- Sponsor's protocol ID
- CMUH103-REC2-058
- Status last verified
- Jun 2015
- First submitted
- 30 Sep 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT02255071
- Acronym / sponsor ID
- CMUH103-REC2-058
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Neiguan, Acupressure, P6
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 2 Oct 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.
In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD.
Detailed description
In recent years, there is an increasing trend in the number of patients with GERD. GERD 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, and chest pain. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. However, the poor response to medicine was still noticed in patients with non-erosive reflux disease. And long-term use of medicine will result in many side effects including infectious, abdominal pain, diarrhea and osteoporosis. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD. 64 patients with GERD were randomly divided into two groups：the acupressure and control. In the acupressure group, in addition to receiving standard treatment, patients will band a hand ring over Neiguan (P6 point) and acupressure for seven days. In the control group, in addition to receiving standard treatment, patients will band a hand ring but no acupressure for seven days. Data was collected by self-recorded symptoms before and after the intervention, according to the Reflux disease questionnaire(RDQ) and the World Health Organization Quality of Life Questionnaire Taiwan condensed version. Data was analyzed by Student's t-tests, Paired Student's t-test, Chi-square, and Fisher exact tests for quantitative and qualitative variables. We anticipate the treatment of Neiguan (P6 point) acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Device: Acupressure wristbandPatients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days. |
| Sham-Acupressure | Sham comparator | Device: Sham wristbandPatients will band a sham wristband over wrist but no acupressure for seven days. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female
- Age of 20-60 years
- Suffered from heartburn with or without acid regurgitation
Key exclusion criteria (4 listed)
- Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
- previously underwent the esophagus, stomach or duodenum surgery
- Lactating women or pregnant women
- patients with severe cardiovascular disease
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 |
|---|---|---|
| Acupressure wristbandA acupressure wristband over Neiguan (P6 point) and acupressure for seven days. | Device | Acupressure |
| Sham wristbandA wristband over wrist but no acupressure for seven days. | Device | Sham-Acupressure |
Primary outcome
Reflux disease questionnaire(RDQ)
Time frame: 7 days
RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.
1 secondary outcome
World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
Wei-Ti Hsu, MD principal investigator
China Medical University 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 Acupressure wristband in people with Gastroesophageal Reflux Disease, run by China Medical University 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 4 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 10 Jun 2015. 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. Some participants in this study may receive a placebo. 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?
Reflux disease questionnaire(RDQ) (time frame: 7 days). 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 10 Jun 2015.