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The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department

Primary Purpose

Dizziness

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Far-Infrared heat-patch attachment
Acupuncture and Fir-Infrared heat-patch attachment
Far-Infrared heat-patch attachment over acupoints without electric current passing.
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with age between 20 to 80-year-old who can cooperate to the whole treatment, testing and questionnaire.
  2. The chief complaint is dizziness which diagnosed by the doctor in charge of the emergency department, in together to exclude the patients with severe unstable vital signs, and then consult for help with Chinese medicine.
  3. Sign the clinical trial agreement sheet.

Exclusion Criteria:

  1. Inacceptable to the research content
  2. Unable to complete the study process
  3. Unwilling to cooperate with acupuncture and other treatments
  4. Abnormal blood clotting profile
  5. With wound or allergy over the treated acupoint
  6. Unstable vital sign
  7. Post major trauma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Acupuncture

    Far-Infrared

    Combination of Acupuncture and Far-Infrared

    Placebo (no Acupuncture nor Far-Infrared)

    Arm Description

    Acupuncture over acupoints.

    Far-Infrared heat-patch attachment over acupoints.

    Acupuncture and Far-Infrared heat-patch attachment over acupoints.

    Far-Infrared heat-patch attachment over acupoints without electric current passing.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS) of dizziness
    acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2020
    Last Updated
    August 3, 2021
    Sponsor
    Changhua Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04415307
    Brief Title
    The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
    Official Title
    The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    principal investigator leave the organization
    Study Start Date
    December 1, 2020 (Actual)
    Primary Completion Date
    August 3, 2021 (Actual)
    Study Completion Date
    August 3, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changhua Christian Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dizziness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm Description
    Acupuncture over acupoints.
    Arm Title
    Far-Infrared
    Arm Type
    Experimental
    Arm Description
    Far-Infrared heat-patch attachment over acupoints.
    Arm Title
    Combination of Acupuncture and Far-Infrared
    Arm Type
    Experimental
    Arm Description
    Acupuncture and Far-Infrared heat-patch attachment over acupoints.
    Arm Title
    Placebo (no Acupuncture nor Far-Infrared)
    Arm Type
    Placebo Comparator
    Arm Description
    Far-Infrared heat-patch attachment over acupoints without electric current passing.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Acupuncture over acupoints.
    Intervention Type
    Other
    Intervention Name(s)
    Far-Infrared heat-patch attachment
    Intervention Description
    Far-Infrared heat-patch attachment over acupoints.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture and Fir-Infrared heat-patch attachment
    Intervention Description
    Acupuncture and Far-Infrared heat-patch attachment over acupoints.
    Intervention Type
    Other
    Intervention Name(s)
    Far-Infrared heat-patch attachment over acupoints without electric current passing.
    Intervention Description
    Far-Infrared heat-patch attachment over acupoints without electric current passing.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS) of dizziness
    Description
    acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment
    Time Frame
    20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with age between 20 to 80-year-old who can cooperate to the whole treatment, testing and questionnaire. The chief complaint is dizziness which diagnosed by the doctor in charge of the emergency department, in together to exclude the patients with severe unstable vital signs, and then consult for help with Chinese medicine. Sign the clinical trial agreement sheet. Exclusion Criteria: Inacceptable to the research content Unable to complete the study process Unwilling to cooperate with acupuncture and other treatments Abnormal blood clotting profile With wound or allergy over the treated acupoint Unstable vital sign Post major trauma

    12. IPD Sharing Statement

    Learn more about this trial

    The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department

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