ACU-ADHDAcupuncture for ADHD in Children
Chinese herbal medicine
+ Acupuncture
Attention Deficit Disorder with Hyperactivity+1
+ Mental Disorders
+ Attention Deficit and Disruptive Behavior Disorders
Treatment Study
Summary
Study start date: October 15, 2024
Actual date on which the first participant was enrolled.Attention Deficit Hyperactivity Disorder (ADHD) is a common condition in children that can make focusing, sitting still, and controlling impulses difficult. This study looks into acupuncture as a possible treatment for children aged 6-12 who have ADHD. While traditional methods like medication and therapy are widely used, this research aims to explore if acupuncture, combined with Chinese herbal treatment, could offer additional benefits. The study is important because it seeks to find alternative ways to help manage ADHD symptoms, potentially leading to more treatment options for families. In this study, participating children will be divided into two groups. One group will receive both acupuncture and traditional Chinese herbal treatment, while the other will only receive herbal treatment. Researchers will measure changes in ADHD symptoms, how well children function day-to-day, their quality of life, and sleep patterns before and after the treatment, and during follow-up visits. The study also includes interviews with children, their parents, and their doctors to gather personal insights on the treatment's effectiveness and satisfaction. This comprehensive approach aims to provide a clearer picture of how acupuncture might help manage ADHD symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 6 to 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patients will be considered for enrolment if they meet the criteria of: * A confirmed diagnosis of ADHD based on the DSM-5 criteria for ADHD (Western medical diagnosis) and in accordance with the ADHD Chinese Medicine Clinical Trial Design and Evaluation Technical Guidelines. * Aged between 6 and 12 years. * No use of any other pharmacological treatments (both Western and traditional Chinese medicine) within the two weeks prior to the start of the study. * An IQ score of greater than 80, as determined by the Raven's Progressive Matrices test. * The participant has not participated in any other clinical trials. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria: * Do not meet the inclusion criteria * Have comorbid psychiatric disorders, severe medical or psychiatric conditions that may interfere with the study (e.g., epilepsy, severe anxiety), pervasive developmental disorders, intellectual disability, or a history of suicidal or self-harming behavior * Have participated in any other drug clinical trials within the past 3 months. * Have severe comorbid conditions such as cardiovascular, hepatic, renal, or hematologic diseases. * Have any other conditions that the researchers believe may interfere with the assessment of treatment efficacy or safety.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, ChinaOpen Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine in Google Maps