<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/NCT04415307</url>
  </required_header>
  <id_info>
    <org_study_id>191250</org_study_id>
    <nct_id>NCT04415307</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department</brief_title>
  <official_title>The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is aimed in patients with persistent dizziness as the chief complaint that is&#xD;
      treated with acupuncture or/and far-infrared heat-patch attachment intervention over the&#xD;
      acupoints for the purpose of dizziness symptoms treatment. The research hypothesis is that&#xD;
      the treatment over acupoints in traditional Chinese medicine is effective in treating&#xD;
      symptoms of dizziness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    principal investigator leave the organization&#xD;
  </why_stopped>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">August 3, 2021</completion_date>
  <primary_completion_date type="Actual">August 3, 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) of dizziness</measure>
    <time_frame>20 minutes</time_frame>
    <description>acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dizziness</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture over acupoints.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Far-Infrared</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Far-Infrared heat-patch attachment over acupoints.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination of Acupuncture and Far-Infrared</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acupuncture and Far-Infrared heat-patch attachment over acupoints.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (no Acupuncture nor Far-Infrared)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Far-Infrared heat-patch attachment over acupoints without electric current passing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture over acupoints.</description>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Far-Infrared heat-patch attachment</intervention_name>
    <description>Far-Infrared heat-patch attachment over acupoints.</description>
    <arm_group_label>Far-Infrared</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture and Fir-Infrared heat-patch attachment</intervention_name>
    <description>Acupuncture and Far-Infrared heat-patch attachment over acupoints.</description>
    <arm_group_label>Combination of Acupuncture and Far-Infrared</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Far-Infrared heat-patch attachment over acupoints without electric current passing.</intervention_name>
    <description>Far-Infrared heat-patch attachment over acupoints without electric current passing.</description>
    <arm_group_label>Placebo (no Acupuncture nor Far-Infrared)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with age between 20 to 80-year-old who can cooperate to the whole treatment,&#xD;
             testing and questionnaire.&#xD;
&#xD;
          2. The chief complaint is dizziness which diagnosed by the doctor in charge of the&#xD;
             emergency department, in together to exclude the patients with severe unstable vital&#xD;
             signs, and then consult for help with Chinese medicine.&#xD;
&#xD;
          3. Sign the clinical trial agreement sheet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inacceptable to the research content&#xD;
&#xD;
          2. Unable to complete the study process&#xD;
&#xD;
          3. Unwilling to cooperate with acupuncture and other treatments&#xD;
&#xD;
          4. Abnormal blood clotting profile&#xD;
&#xD;
          5. With wound or allergy over the treated acupoint&#xD;
&#xD;
          6. Unstable vital sign&#xD;
&#xD;
          7. Post major trauma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Dizziness</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/NCT04415307
org study id: 191250
nct id: NCT04415307
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is aimed in patients with persistent dizziness as the chief complaint that is
      treated with acupuncture or/and far-infrared heat-patch attachment intervention over the
      acupoints for the purpose of dizziness symptoms treatment. The research hypothesis is that
      the treatment over acupoints in traditional Chinese medicine is effective in treating
      symptoms of dizziness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Visual Analog Scale (VAS) of dizziness
time frame: 20 minutes
description: acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment
arm group label: Acupuncture
arm group type: Experimental
description: Acupuncture over acupoints.
arm group label: Far-Infrared
arm group type: Experimental
description: Far-Infrared heat-patch attachment over acupoints.
arm group label: Combination of Acupuncture and Far-Infrared
arm group type: Experimental
description: Acupuncture and Far-Infrared heat-patch attachment over acupoints.
arm group label: Placebo (no Acupuncture nor Far-Infrared)
arm group type: Placebo Comparator
description: Far-Infrared heat-patch attachment over acupoints without electric current passing.
intervention type: Other
intervention name: Acupuncture
description: Acupuncture over acupoints.
arm group label: Acupuncture
intervention type: Other
intervention name: Far-Infrared heat-patch attachment
description: Far-Infrared heat-patch attachment over acupoints.
arm group label: Far-Infrared
intervention type: Other
intervention name: Acupuncture and Fir-Infrared heat-patch attachment
description: Acupuncture and Far-Infrared heat-patch attachment over acupoints.
arm group label: Combination of Acupuncture and Far-Infrared
intervention type: Other
intervention name: Far-Infrared heat-patch attachment over acupoints without electric current passing.
description: Far-Infrared heat-patch attachment over acupoints without electric current passing.
arm group label: Placebo (no Acupuncture nor Far-Infrared)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Emergencies
mesh term: Dizziness