Anorexia in ChildrenNCT06619548
The Clinical Research of Auricular Magnet for Anorexia in Children
A study testing Auricular magnet with a magnetic strength of 1800 Gauss and Auricular magnet with no magnetic strength in people with Anorexia in Children, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Anorexia in Children
- What is being tested?
- Auricular magnet with a magnetic strength of 1800 Gauss and Auricular magnet with no magnetic strength
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2024to Jul 2025
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Congenital abnormalities of the digestive tract, cancer, and other major illnesses, or unwillingness to cooperate with testing.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Hung-Rong Yen, 04-22053366 ext. 3501, hungrongyen@gmail.com
About this study
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.
Read the 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.
- Conditions
- Anorexia in Children
- Being tested
- Auricular magnet with a magnetic strength of 1800 Gauss, Auricular magnet with no magnetic strength
- Keywords
- anorexia in children, traditional Chinese medicine, auricular point, clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular magnet with a magnetic strength of 1800 GaussOther
Auricular magnets with a magnetic strength of 1800 Gauss are used as the experimental group.
Auricular magnet with no magnetic strengthOther
Auricular magnets with no magnetic strength are used as placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: Auricular magnet with a magnetic strength of 1800 Gauss; Other: Auricular magnet with no magnetic strength |
| Group B | Placebo comparator | 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. Receives: Other: Auricular magnet with a magnetic strength of 1800 Gauss; Other: Auricular magnet with no magnetic strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating behavior change
The eating behavior is evaluated by the Preschooler's Eating Behavior Scale questionnaire.
Measured: 0, 7, 21, 28 days
Secondary outcomes (1)
Body Mass Index (BMI) change
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.
Measured: 0, 7, 21, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia in ChildrenStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Rong Yen, China Medical University Hospital
- Investigators
- Hung-Rong Yen, M.D., Ph.D., Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619548
- Sponsor's protocol ID
- CMUH112-REC1-108
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Auricular Magnet for Anorexia in Children
- ClinicalTrials.gov ID
- NCT06619548
- Acronym / sponsor ID
- CMUH112-REC1-108
- Conditions
- Anorexia in Children
- Keywords
- anorexia in children, traditional Chinese medicine, auricular point, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 1 Oct 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Auricular magnet with a magnetic strength of 1800 Gauss, Other: Auricular magnet with no magnetic strengthThe 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. |
| Group B | Placebo comparator | Other: Auricular magnet with a magnetic strength of 1800 Gauss, Other: Auricular magnet with no magnetic strengthThe 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The pediatric patient has one or more of the following symptoms (at least once a week and lasting 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.
Key exclusion criteria (1 listed)
- Congenital abnormalities of the digestive tract, cancer, and other major illnesses, or unwillingness to cooperate with testing.
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 |
|---|---|---|
| Auricular magnet with a magnetic strength of 1800 GaussAuricular magnets with a magnetic strength of 1800 Gauss are used as the experimental group. | Other | Group A, Group B |
| Auricular magnet with no magnetic strengthAuricular magnets with no magnetic strength are used as placebo control. | Other | Group A, Group B |
Primary outcome
Eating behavior change
Time frame: 0, 7, 21, 28 days
The eating behavior is evaluated by the Preschooler's Eating Behavior Scale questionnaire.
1 secondary outcome
Body Mass Index (BMI) change
Time frame: 0, 7, 21, 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
Hung-Rong Yen, M.D., Ph.D. study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular magnet with a magnetic strength of 1800 Gauss and Auricular magnet with no magnetic strength in people with Anorexia in Children, run by China Medical University Hospital at 1 site in Taiwan.
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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Rong Yen, M.D., Ph.D. (04-22053366 ext. 3501, hungrongyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating behavior change (time frame: 0, 7, 21, 28 days). 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 1 Oct 2024.