Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction

Last updated: December 12, 2024
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Intermittent low carbohydrate diet

Health education

Auricular acupressure of traditional Chinese Medicine

Clinical Study ID

NCT05847478
AP_IDR_2.0
  • Ages 6-18
  • All Genders

Study Summary

This is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus Intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have at least one of the following cardiometabolic risk factors: overweight orobesity, prediabetes, dyslipidemia or elevated blood pressure.

  • Traditional Chinese medical syndrome type is gastric heat and dampness obstructionsyndrome.

Exclusion

Exclusion Criteria:

  • Diagnosis of obesity associated with genetic or endocrine diseases, includinghypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamicobesity.

  • Participating in other clinical trials or have participated in other clinical trialsin recent 3 months.

  • Diagnosis of organic diseases, including heart, liver, kidney and brain orinfectious diseases and mental diseases.

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Intermittent low carbohydrate diet
Phase:
Study Start date:
June 07, 2023
Estimated Completion Date:
December 31, 2025

Study Description

Obesity in childhood is associated with multiple cardiometabolic risk factors including hyperglycemia, dyslipidemia and hypertension, which predicts increased risk for developing obesity-driven complications in adulthood. Auricular acupuncture therapy is an intervention with purported success for the treatment of obesity. However, traditional intervention rarely has long-term success in children and adolescents. Low-carbohydrate diets have also been shown to reduce body weight and improve insulin sensitivity in children.

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.

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai, 201102
    China

    Active - Recruiting

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