Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
NCT ID: NCT05847478
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-06-07
2025-12-31
Brief Summary
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Detailed Description
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This is a three-month randomized controlled trial in children with gastric damp-heat obstruction, in order to explore the effects of traditional Chinese medicine auricular acupressure and intermittent carbohydrate restriction on cardiovascular metabolic health.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Auricular acupressure therapy group (AAT)
The participants will be randomly assigned to receive the auricular point patch therapy. The intervention period is 3 months.
Auricular acupressure of traditional Chinese Medicine
The participants will be randomly assigned to receive the auricular point patch therapy.
The selected acupoints include Shenmen, hungry point, endocrine, stomach, mouth and subcortical. The opaque patch with vaccaria seed is used for acupoint pressing. Pressing the acupoints once a day before and after eating, each time for 1 minute, lasting for 2-3 days, follow up visit once a week. The intervention period is 3 months.
Health education
Health education is conducted once a week during 3-month intervention for all participants. Health education including the understanding of childhood obesity and cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
Intermittent low carbohydrate diet group (ILCD)
The participants will be randomly assigned to receive the intermittent low carbohydrate diet. The duration of the study is 3 months, including 1-month intervention period and 2-month self maintenance period.
Intermittent low carbohydrate diet
The participants will be randomly assigned to the intermittent low carbohydrate diet group.
The intermittent carbohydrate diet includes 7 days of low carbohydrate diet within 2 weeks (consecutive or nonconsecutive, carbohydrate intake be controlled as ≤ 50g per day). The study duration is 3 months, including 1-month intervention period and 2-month self-maintenance period.
Health education
Health education is conducted once a week during 3-month intervention for all participants. Health education including the understanding of childhood obesity and cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
Interventions
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Auricular acupressure of traditional Chinese Medicine
The participants will be randomly assigned to receive the auricular point patch therapy.
The selected acupoints include Shenmen, hungry point, endocrine, stomach, mouth and subcortical. The opaque patch with vaccaria seed is used for acupoint pressing. Pressing the acupoints once a day before and after eating, each time for 1 minute, lasting for 2-3 days, follow up visit once a week. The intervention period is 3 months.
Intermittent low carbohydrate diet
The participants will be randomly assigned to the intermittent low carbohydrate diet group.
The intermittent carbohydrate diet includes 7 days of low carbohydrate diet within 2 weeks (consecutive or nonconsecutive, carbohydrate intake be controlled as ≤ 50g per day). The study duration is 3 months, including 1-month intervention period and 2-month self-maintenance period.
Health education
Health education is conducted once a week during 3-month intervention for all participants. Health education including the understanding of childhood obesity and cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
Eligibility Criteria
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Inclusion Criteria
* Traditional Chinese medical syndrome type is gastric heat and dampness obstruction syndrome.
Exclusion Criteria
* Participating in other clinical trials or have participated in other clinical trials in recent 3 months.
* Diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.
6 Years
18 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Children's Hospital of Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Wen Sun
Role: primary
References
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Sun W, He J, Wang W, Lu C, Lin Y, Dou Y, Yan W, Yu J. Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 3;14:e59856. doi: 10.2196/59856.
Other Identifiers
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AP_IDR_2.0
Identifier Type: -
Identifier Source: org_study_id