The Efficacy and Safety of Traditional Chinese Medicine (... | NCT04415307

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

NCT04415307

Sponsor

Changhua Christian Hospital

Status

Withdrawn

Last Update Posted

Aug 9, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Dizziness

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

principal investigator leave the organization

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Aug 3, 2021Actual

Completion Date

Aug 3, 2021Actual

First Submitted Date

Jun 1, 2020

First Submission Date that Met QC Criteria

Jun 1, 2020

First Posted Date

Jun 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2021

Last Update Posted Date

Aug 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acupuncture	Experimental	Acupuncture over acupoints.	Other: Acupuncture
Far-Infrared	Experimental	Far-Infrared heat-patch attachment over acupoints.	Other: Far-Infrared heat-patch attachment
Combination of Acupuncture and Far-Infrared	Experimental	Acupuncture and Far-Infrared heat-patch attachment over acupoints.	Other: Acupuncture and Fir-Infrared heat-patch attachment
Placebo (no Acupuncture nor Far-Infrared)	Placebo Comparator	Far-Infrared heat-patch attachment over acupoints without electric current passing.	Other: Far-Infrared heat-patch attachment over acupoints without electric current passing.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Other	Acupuncture over acupoints.	Acupuncture
Far-Infrared heat-patch attachment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics