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NCT Number: NCT06619548

The Clinical Research of Auricular Magnet for Anorexia in Children

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, Taiwan

Location status: Recruiting

Location contact

Hung-Rong Yen

CONTACT

[email protected]

04-22053366 ext. 3501

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular magnet with a magnetic strength of 1800 Gauss

Other

Auricular magnets with a magnetic strength of 1800 Gauss are used as the experimental group.

Auricular magnet with no magnetic strength

Other

Auricular magnets with no magnetic strength are used as placebo control.

Primary outcomes

  1. Eating behavior change

    Time frame: 0, 7, 21, 28 days

    The eating behavior is evaluated by the Preschooler's Eating Behavior Scale questionnaire.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hung-Rong Yen, M.D., Ph.D.

CONTACT

[email protected]

04-22053366 ext. 3501

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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