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临床试验/NCT06619548
NCT06619548招募中不适用

The Clinical Research of Auricular Magnet for Anorexia in Children

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
144
试验地点
1
主要终点
Eating behavior change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Eating behavior change

时间窗: 0, 7, 21, 28 days

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

次要结局

  • Body Mass Index (BMI) change(0, 7, 21, 28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hung-Rong Yen

Director of the Department of Integration of Traditional Chinese-Western Medicine

China Medical University Hospital

研究点 (1)

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