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Withdrawn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
About this trial
This is an interventional treatment trial for Dizziness
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
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
NCT ID
NCT04415307
First Posted
June 1, 2020
Last Updated
August 3, 2021
Sponsor
Changhua Christian Hospital
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Withdrawn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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