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

August 3, 2021 updated by: Changhua Christian Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture over acupoints.
Other: Acupuncture
Acupuncture over acupoints.
Experimental: Far-Infrared
Far-Infrared heat-patch attachment over acupoints.
Other: Far-Infrared heat-patch attachment
Far-Infrared heat-patch attachment over acupoints.
Experimental: Combination of Acupuncture and Far-Infrared
Acupuncture and Far-Infrared heat-patch attachment over acupoints.
Other: Acupuncture and Fir-Infrared heat-patch attachment
Acupuncture and Far-Infrared heat-patch attachment over acupoints.
Placebo Comparator: Placebo (no Acupuncture nor Far-Infrared)
Far-Infrared heat-patch attachment over acupoints without electric current passing.
Other: Far-Infrared heat-patch attachment over acupoints without electric current passing.
Far-Infrared heat-patch attachment over acupoints without electric current passing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) of dizziness
Time Frame: 20 minutes
acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

August 3, 2021

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191250

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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