The Clinical Research of Auricular Magnet for Anorexia in Children
September 27, 2024 updated by: Hung-Rong Yen, China Medical University Hospital
The aim of this randomized controlled cross-over trial is to explore the efficacy of auricular magnet in treating childhood anorexia.
Participants will be allocated to two groups, labeled as Group A and Group B. Prior to the commencement of the trial, parents or guardians of the participants are required to fill out basic information for their children, including age, gender, height, weight, etc., and to complete the Preschooler's Eating Behavior Scale questionnaire.
Over the initial 7-day period, participants of Group A receive auricular magnet therapy while participants of Group B undergo placebo magnetic auricular therapy.
This is followed by a 14-day washout period to eliminate any lingering effects from the initial treatment.
In the second phase, the treatments are swapped between the two groups.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Anorexia in children refers to a disease in which children are not greedy for food for a long time, lose their appetite, and even refuse to eat.
From the perspective of Western medicine, anorexia is classified as an eating disorder, and its causes are quite diverse, such as digestive tract diseases, neurological abnormalities, etc. From the perspective of traditional Chinese medicine (TCM), normal spleen and stomach functions are necessary for food digestion.
If the spleen and stomach are not in harmony, it will cause symptoms of not breastfeeding and eating.
TCM treatment of anorexia in children can be divided into two types: internal treatment and external treatment.
The method of internal treatment is to give appropriate prescriptions to patients through syndrome identification and treatment.
The methods of external treatment include massage, acupoint sticking, auricular point sticking, scraping therapy, navel pushing therapy, acupuncture and moxibustion, etc.
Because children with anorexia do not like to eat, it is not easy to treat anorexia with drugs alone.
External therapy can be considered.
As traditional medicine is getting more and more attention, many patients seek TCM adjuvant treatment.
This study discusses auricular point sticking in external therapy.
Auricular point sticking has the advantages of noninvasiveness and convenient operation, and is suitable for children's diseases.
However, the current studies on auricular points for children with anorexia are still mostly using the traditional buliuxing seeds, and there is a lack of rigorous clinical research.
The aim of this study is to establish a clinical trial of auricular magnets in the treatment of anorexia in children.
It is expected that subjects will be recruited from the Department of Traditional Chinese Medicine of the Affiliated Hospital of China Medical University, and the changes in eating behavior before and after treatment will be evaluated by questionnaires to explore the efficacy of auricular magnets.
Study Type
Interventional
Enrollment (Estimated)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hung-Rong Yen, M.D., Ph.D.
- Phone Number: 3501 04-22053366
- Email: hungrongyen@gmail.com
Study Locations
-
-
-
Taichung, Taiwan
- Recruiting
- China Medical University Hospital
-
Contact:
- Hung-Rong Yen
- Phone Number: 3501 04-22053366
- Email: hungrongyen@gmail.com
-
-
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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
The pediatric patient has one or more of the following symptoms (at least once a week and lasting for at least two months):
- Postprandial fullness
- Early satiety
- Epigastric pain
- Epigastric burning sensation or has a weight below the 15th percentile for age and sex for at least two months.
- No prokinetic or appetite-stimulating Western medications or spleen and stomach-strengthening Chinese medications have been used within the past two weeks.
Exclusion Criteria:
Congenital abnormalities of the digestive tract, cancer, and other major illnesses, or unwillingness to cooperate with testing.
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
The participants will have auricular magnets with a strength of 1800 Gauss applied to specific acupoints in the first treatment phase.
This is followed by a 14-day washout period.
In the second treatment phase, the participants will have auricular magnets with no magnetic strength applied to the same acupoints.
|
Auricular magnets with a magnetic strength of 1800 Gauss are used as the experimental group.
Auricular magnets with no magnetic strength are used as placebo control.
|
|
Placebo Comparator: Group B
The participants will have auricular magnets with no magnetic strength applied to specific acupoints in the first treatment phase.
This is followed by a 14-day washout period.
In the second treatment phase, the participants will have auricular magnets with a strength of 1800 Gauss applied to the same acupoints.
|
Auricular magnets with a magnetic strength of 1800 Gauss are used as the experimental group.
Auricular magnets with no magnetic strength are used as placebo control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating behavior change
Time Frame: 0, 7, 21, 28 days
|
The eating behavior is evaluated by the Preschooler's Eating Behavior Scale questionnaire.
|
0, 7, 21, 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index (BMI) change
Time Frame: 0, 7, 21, 28 days
|
We will compare the changes in BMI values for the same patient before and after the trial to assess the effect of auricular magnets on weight.
|
0, 7, 21, 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hung-Rong Yen, M.D., Ph.D., China Medical University, China
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 (Estimated)
October 1, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
September 27, 2024
First Submitted That Met QC Criteria
September 27, 2024
First Posted (Actual)
October 1, 2024
Study Record Updates
Last Update Posted (Actual)
October 1, 2024
Last Update Submitted That Met QC Criteria
September 27, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH112-REC1-108
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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