The Clinical Research of Auricular Magnet for Anorexia in Children

NCT06619548 | Recruiting DMC

• 1 other identifier: CMUH112-REC1-108
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anorexia in Children

Keywords

anorexia in children; traditional Chinese medicine; auricular point; clinical trial

Outcome Measures

Primary Outcomes (1)

• Eating behavior change

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

  0, 7, 21, 28 days

Secondary Outcomes (1)

• Body Mass Index (BMI) change

  0, 7, 21, 28 days

Study Arms (2)

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.

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.

Other: Auricular magnet with a magnetic strength of 1800 Gauss; Other: Auricular magnet with no magnetic strength

Interventions

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.

Group A; Group B

Auricular magnet with no magnetic strength OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Congenital abnormalities of the digestive tract, cancer, and other major illnesses, or unwillingness to cooperate with testing.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

Study Officials

• Hung-Rong Yen, M.D., Ph.D.

  China Medical University, China

  STUDY CHAIR

Central Study Contacts

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

CONTACT

04-22053366; hungrongyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Integration of Traditional Chinese-Western Medicine

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

TW (1)