<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02255071</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH103-REC2-058</org_study_id>
    <nct_id>NCT02255071</nct_id>
  </id_info>
  <brief_title>The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)</brief_title>
  <official_title>The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years, there is an increasing trend in the number of patients with Gastroesophageal&#xD;
      reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive&#xD;
      reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan&#xD;
      (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen.&#xD;
      Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6&#xD;
      point) acupressure in patients with GERD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, there is an increasing trend in the number of patients with GERD. GERD&#xD;
      mainly related to the reflux of stomach content induced by the dysfunction of lower&#xD;
      esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, and&#xD;
      chest pain. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux&#xD;
      surgery and endoscopy. However, the poor response to medicine was still noticed in patients&#xD;
      with non-erosive reflux disease. And long-term use of medicine will result in many side&#xD;
      effects including infectious, abdominal pain, diarrhea and osteoporosis. According to the&#xD;
      theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the&#xD;
      uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to&#xD;
      investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD. 64&#xD;
      patients with GERD were randomly divided into two groups：the acupressure and control. In the&#xD;
      acupressure group, in addition to receiving standard treatment, patients will band a hand&#xD;
      ring over Neiguan (P6 point) and acupressure for seven days. In the control group, in&#xD;
      addition to receiving standard treatment, patients will band a hand ring but no acupressure&#xD;
      for seven days. Data was collected by self-recorded symptoms before and after the&#xD;
      intervention, according to the Reflux disease questionnaire(RDQ) and the World Health&#xD;
      Organization Quality of Life Questionnaire Taiwan condensed version. Data was analyzed by&#xD;
      Student's t-tests, Paired Student's t-test, Chi-square, and Fisher exact tests for&#xD;
      quantitative and qualitative variables. We anticipate the treatment of Neiguan (P6 point)&#xD;
      acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of&#xD;
      life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reflux disease questionnaire(RDQ)</measure>
    <time_frame>7 days</time_frame>
    <description>RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)</measure>
    <time_frame>7 days</time_frame>
    <description>WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Acupressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-Acupressure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will band a sham wristband over wrist but no acupressure for seven days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupressure wristband</intervention_name>
    <description>A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.</description>
    <arm_group_label>Acupressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham wristband</intervention_name>
    <description>A wristband over wrist but no acupressure for seven days.</description>
    <arm_group_label>Sham-Acupressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female&#xD;
&#xD;
          2. Age of 20-60 years&#xD;
&#xD;
          3. Suffered from heartburn with or without acid regurgitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus&#xD;
&#xD;
          2. previously underwent the esophagus, stomach or duodenum surgery&#xD;
&#xD;
          3. Lactating women or pregnant women&#xD;
&#xD;
          4. patients with severe cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Ti Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>June 8, 2015</last_update_submitted>
  <last_update_submitted_qc>June 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GERD</keyword>
  <keyword>Neiguan</keyword>
  <keyword>Acupressure</keyword>
  <keyword>P6</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255071
org study id: CMUH103-REC2-058
nct id: NCT02255071
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Reflux disease questionnaire(RDQ)
time frame: 7 days
description: RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.
measure: World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
time frame: 7 days
description: WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.
arm group label: Acupressure
arm group type: Experimental
description: Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
arm group label: Sham-Acupressure
arm group type: Sham Comparator
description: Patients will band a sham wristband over wrist but no acupressure for seven days.
intervention type: Device
intervention name: Acupressure wristband
description: A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
arm group label: Acupressure
intervention type: Device
intervention name: Sham wristband
description: A wristband over wrist but no acupressure for seven days.
arm group label: Sham-Acupressure
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Wei-Ti Hsu, MD
role: Principal Investigator
affiliation: China Medical University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic