- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02358239
Efficacy and Safety of Acupuncture for Dizziness and Vertigo in Emergency Department: a Clinical Control Trial
February 3, 2015 updated by: Po-Chi Hsu
Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED).
Pharmacological therapy is often solicited for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines.
However, every medication is accompanied with unavoidable side-effects.
To the best of the investigators knowledge, no papers surveyed assess the feasibility of applying acupuncture as an emergent intervention means to the treatment of dizziness and vertigo.
The investigators study targeted on filling in this gap by performing a clinical control trial to evaluate the efficacy and safety of traditional Chinese medicine - acupuncture - in treating patients with dizziness and vertigo in ED.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Visit emergency department and stay in observation unit.
- Consult otolaryngologist and neurologist to rule in dizziness and giddiness, auditory vertigo, vertebrobasilar artery syndrome, and peripheral vestibular disorders - Ménière's disease, benign paroxymal peripheral vertigo, and vestibular neuritis.
Exclusion Criteria:
- Serious comorbid conditions (for example, life-threatening condition or progressive central disorder).
- Patients who cannot communicate reliably with the investigator or who are not likely to obey the instructions of the trial.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Efficacy and safety of acupuncture for dizziness and vertigo
To evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED.
|
Experiment group received acupuncture at Zusanli (ST36) and Neiguan (PC6) acupuncture points
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual Analog Scale (VAS) of dizziness
Time Frame: after the first 30 minutes after acupuncture
|
after the first 30 minutes after acupuncture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
February 3, 2015
First Posted (Estimate)
February 6, 2015
Study Record Updates
Last Update Posted (Estimate)
February 6, 2015
Last Update Submitted That Met QC Criteria
February 3, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120403
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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