<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/NCT03805035</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH107-REC3-019</org_study_id>
    <nct_id>NCT03805035</nct_id>
  </id_info>
  <brief_title>Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research</brief_title>
  <official_title>Anti-histamines Promote Electroacupuncture Analgesia: Basic and Clinical Research</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is&#xD;
      increasingly practiced worldwide. The effects of acupuncture in chronic pain have been&#xD;
      investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for&#xD;
      treating allergy. Recently, investigators found that histamine H1 receptor antagonists at&#xD;
      relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing&#xD;
      test. Investigators aim to further explore whether histamine H1 receptor antagonists also&#xD;
      facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical&#xD;
      trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA&#xD;
      analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged&#xD;
      between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham&#xD;
      acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at&#xD;
      ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36&#xD;
      and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain&#xD;
      threshold. It is expected that the completion of this proposed study will enhance our&#xD;
      knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a&#xD;
      low dose and help to define its application for clinical use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)</measure>
    <time_frame>baseline and 10min after treatment</time_frame>
    <description>Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>sham EA group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Minimal needling at ST36 and GB34 (n=10)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>true EA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EA at ST36 and GB34 (n=10)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EA+antihistamine(low dose) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EA+antihistamine(high dose) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electroacupuncture</intervention_name>
    <description>Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)</description>
    <arm_group_label>EA+antihistamine(high dose) group</arm_group_label>
    <arm_group_label>EA+antihistamine(low dose) group</arm_group_label>
    <arm_group_label>true EA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)</intervention_name>
    <description>Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)</description>
    <arm_group_label>EA+antihistamine(low dose) group</arm_group_label>
    <other_name>chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)</intervention_name>
    <description>Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)</description>
    <arm_group_label>EA+antihistamine(high dose) group</arm_group_label>
    <other_name>chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Minimal needling at ST36 and GB34</description>
    <arm_group_label>sham EA group</arm_group_label>
    <other_name>shallow needling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. . Age: 20 to 30 years of age.&#xD;
&#xD;
          2. . Agrees to undergo a comprehensive medical history and physical examination.&#xD;
&#xD;
          3. . No history of analgesic, sedative, dietary/appetite medication intake for more than&#xD;
             3 weeks prior to enrolment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. . An ongoing medical condition that requires active medical intervention or monitoring&#xD;
             to avert serious danger to the participant's health or well-being (e.g., hypertension,&#xD;
             diabetes mellitus, or epilepsy).&#xD;
&#xD;
          2. . A compromised skin barrier (e.g., skin disease, allergy) that would interfere with&#xD;
             the conduct of the EA procedure and assessments of the study.&#xD;
&#xD;
          3. . An implant such as a pacemaker, defibrillator, or electronic medical equipment.&#xD;
&#xD;
          4. . Pregnancy, or planning for pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Hung Chen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Graduate Institute of Acupuncture Science, China Medical University</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>
  <reference>
    <citation>Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.</citation>
    <PMID>1351926</PMID>
  </reference>
  <reference>
    <citation>Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.</citation>
    <PMID>14698480</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electroacupuncture (EA)</keyword>
  <keyword>Antihistamine</keyword>
  <keyword>Pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorpheniramine</mesh_term>
    <mesh_term>Maleic acid</mesh_term>
    <mesh_term>Histamine Antagonists</mesh_term>
    <mesh_term>Dexchlorpheniramine</mesh_term>
    <mesh_term>Histamine H1 Antagonists</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03805035
org study id: CMUH107-REC3-019
nct id: NCT03805035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acupuncture has been used in traditional Chinese medicine for around 3,000 years and is
      increasingly practiced worldwide. The effects of acupuncture in chronic pain have been
      investigated in many clinical trials. Histamine H1 receptor antagonists are commonly used for
      treating allergy. Recently, investigators found that histamine H1 receptor antagonists at
      relatively low doses facilitate EA analgesia in the acetic acid-induced abdominal writhing
      test. Investigators aim to further explore whether histamine H1 receptor antagonists also
      facilitate EA analgesia in humans.The aims of the proposed studies are to: Conduct a clinical
      trial to demonstrate that H1 receptor antagonists at relatively low doses facilitate EA
      analgesia in healthy volunteers. This study will recruit 40 healthy normal subjects (aged
      between 20 and 30 years) who will be randomly assigned to one of four groups: (1) Sham
      acupuncture (Shallow needling without electrical stimulation) at ST36 and GB34; (2) EA at
      ST36 and GB34; (3) EA at ST36 and GB34 plus low-dose chlorpheniramine (2 mg); (4) EA at ST36
      and GB34 plus regular-dose chlorpheniramine (4 mg). The primary endpoint will be the pain
      threshold. It is expected that the completion of this proposed study will enhance our
      knowledge as to how acupuncture analgesia can be promoted by antihistamine drugs given at a
      low dose and help to define its application for clinical use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: pain threshold in each group:the current intensity of Transcutaneous electrical stimulation (TCES)
time frame: baseline and 10min after treatment
description: Transcutaneous electrical stimulation (TCES) is used as a method of inducing pain in the study. The procedure is to attach two electrode patches on the inside of the upper arm of the subject and then connect the electric stimulator. The current intensity will gradually increase from 0 mA, and each time increase 0.5amps until the subject feels pain in the visual analogy. Transcutaneous electrical stimulation (TCES) will be stopped at the visual analog scale of 5 (that means the moderate pain). The current intensity will be compared within and between each group.
arm group label: sham EA group
arm group type: Sham Comparator
description: Minimal needling at ST36 and GB34 (n=10)
arm group label: true EA group
arm group type: Experimental
description: EA at ST36 and GB34 (n=10)
arm group label: EA+antihistamine(low dose) group
arm group type: Active Comparator
description: EA at ST36 and GB34 plus low-dose chlorpheniramine( Dexchlorpheniramine maleate 2mg/tab, 1 tab; n=10)
arm group label: EA+antihistamine(high dose) group
arm group type: Active Comparator
description: EA at ST36 and GB34 plus high-dose chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 2 tabs; n=10)
intervention type: Device
intervention name: electroacupuncture
description: Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
arm group label: EA+antihistamine(high dose) group
arm group label: EA+antihistamine(low dose) group
arm group label: true EA group
intervention type: Drug
intervention name: antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)
description: Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
arm group label: EA+antihistamine(low dose) group
other name: chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab)
intervention type: Drug
intervention name: antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)
description: Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
arm group label: EA+antihistamine(high dose) group
other name: chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs)
intervention type: Device
intervention name: acupuncture
description: Minimal needling at ST36 and GB34
arm group label: sham EA group
other name: shallow needling
criteria: 
gender: All
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yi-Hung Chen, PhD
role: Study Director
affiliation: Graduate Institute of Acupuncture Science, China Medical University
facility: 
country: Taiwan
citation: Traiffort E, Pollard H, Moreau J, Ruat M, Schwartz JC, Martinez-Mir MI, Palacios JM. Pharmacological characterization and autoradiographic localization of histamine H2 receptors in human brain identified with [125I]iodoaminopotentidine. J Neurochem. 1992 Jul;59(1):290-9. doi: 10.1111/j.1471-4159.1992.tb08903.x.
PMID: 1351926
citation: Zhang WT, Jin Z, Luo F, Zhang L, Zeng YW, Han JS. Evidence from brain imaging with fMRI supporting functional specificity of acupoints in humans. Neurosci Lett. 2004 Jan 2;354(1):50-3. doi: 10.1016/j.neulet.2003.09.080.
PMID: 14698480
responsible party type: Sponsor
mesh term: Chlorpheniramine
mesh term: Maleic acid
mesh term: Histamine Antagonists
mesh term: Dexchlorpheniramine
mesh term: Histamine H1 Antagonists
sharing ipd: No