DizzinessNCT04415307
The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
A study testing Acupuncture, Far-Infrared heat-patch attachment and Acupuncture and Fir-Infrared heat-patch attachment in people with Dizziness, run by Changhua Christian Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dizziness
- What is being tested?
- Acupuncture, Far-Infrared heat-patch attachment and Acupuncture and Fir-Infrared heat-patch attachment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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.
- Conditions
- Dizziness
- Being tested
- Acupuncture, Far-Infrared heat-patch attachment, Acupuncture and Fir-Infrared heat-patch attachment, Far-Infrared heat-patch attachment over acupoints without electric current passing.
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture over acupoints.
Far-Infrared heat-patch attachmentOther
Far-Infrared heat-patch attachment over acupoints.
Acupuncture and Fir-Infrared heat-patch attachmentOther
Acupuncture and Far-Infrared heat-patch attachment over acupoints.
Far-Infrared heat-patch attachment over acupoints without electric current passing.Other
Far-Infrared heat-patch attachment over acupoints without electric current passing.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture over acupoints. Receives: Other: Acupuncture |
| Far-Infrared | Experimental | Far-Infrared heat-patch attachment over acupoints. Receives: Other: Far-Infrared heat-patch attachment |
| Combination of Acupuncture and Far-Infrared | Experimental | Acupuncture and Far-Infrared heat-patch attachment over acupoints. Receives: 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. Receives: Other: Far-Infrared heat-patch attachment over acupoints without electric current passing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) of dizziness
acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Dec 2020
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Why it stopped: principal investigator leave the organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415307
- Sponsor's protocol ID
- 191250
- Status last verified
- Aug 2021
- First submitted
- 1 Jun 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Traditional Chinese Medicine (TCM) to the Patient With Dizziness in Emergency Department
- ClinicalTrials.gov ID
- NCT04415307
- Acronym / sponsor ID
- 191250
- Conditions
- Dizziness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: principal investigator leave the organization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureAcupuncture over acupoints. |
| Far-Infrared | Experimental | Other: Far-Infrared heat-patch attachmentFar-Infrared heat-patch attachment over acupoints. |
| Combination of Acupuncture and Far-Infrared | Experimental | Other: Acupuncture and Fir-Infrared heat-patch attachmentAcupuncture and Far-Infrared heat-patch attachment over acupoints. |
| Placebo (no Acupuncture nor Far-Infrared) | Placebo comparator | Other: Far-Infrared heat-patch attachment over acupoints without electric current passing.Far-Infrared heat-patch attachment over acupoints without electric current passing. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture over acupoints. | Other | Acupuncture |
| Far-Infrared heat-patch attachmentFar-Infrared heat-patch attachment over acupoints. | Other | Far-Infrared |
| Acupuncture and Fir-Infrared heat-patch attachmentAcupuncture and Far-Infrared heat-patch attachment over acupoints. | Other | Combination of Acupuncture and Far-Infrared |
| Far-Infrared heat-patch attachment over acupoints without electric current passing.Far-Infrared heat-patch attachment over acupoints without electric current passing. | Other | Placebo (no Acupuncture nor Far-Infrared) |
Primary outcome
Visual Analog Scale (VAS) of dizziness
Time frame: 20 minutes
acupoints intervention of acupuncture or/and Far-Infrared heat-patch attachment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Far-Infrared heat-patch attachment and Acupuncture and Fir-Infrared heat-patch attachment in people with Dizziness, run by Changhua Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) of dizziness (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.