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Leczenie akupunktury ADHD: wydobycie danych ACUPINTS poprzez przegląd literatury, skuteczność kliniczna, bezpieczeństwo i wywiady jakościowe w celu zbadania wyników i spostrzeżeń leczenia (ACU-ADHD). (ACU-ADHD)

3 listopada 2026 zaktualizowane przez: Tananan Sangwanit, The Third Affiliated Hospital of Beijing University of Chinese Medicine

Badanie kliniczne dotyczące leczenia akupunktury w przypadku zaburzenia nadpobudliwości z deficytem uwagi.

This study aims to evaluate the efficacy of acupuncture as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-12 years. Using a mixed-methods approach, the research will triangulate data from acupoint data mining, treatment outcomes assessment, and patient perspectives to provide a comprehensive analysis of acupuncture's potential therapeutic benefits for ADHD.

This prospective cohort study will recruit children diagnosed with ADHD, assigning them to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessments using the the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI that will be complemented by qualitative interviews to capture nuanced patient experiences and treatment outcomes.

The study will span 12 months, commencing on March 1st, 2025 with an expected completion by February 28th, 2026. By integrating quantitative assessments with qualitative insights, it aims to provide comprehensive evidence on acupuncture's role in ADHD management. Findings may inform clinical guidelines and enhance patient-centered care approaches.

Przegląd badań

Szczegółowy opis

Attention Deficit Hyperactivity Disorder (ADHD) remains a prevalent neurodevelopmental disorder affecting children worldwide, often characterized by persistent patterns of inattention, hyperactivity, and impulsivity that significantly impair daily functioning. While conventional treatments such as stimulant medications and behavioral therapies are commonly prescribed, interest in complementary and alternative approaches, including acupuncture, has grown. This study proposes a rigorous examination of acupuncture's potential efficacy as a treatment modality for ADHD, employing a mixed-methods approach to triangulate acupoint data mining, treatment outcomes assessment, and patient perspectives.

The primary objective is to evaluate the therapeutic effects of acupuncture in children aged 6-12 years diagnosed with ADHD. The research design involves a prospective cohort study wherein participants will be allocated to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessment of ADHD symptom and related impairment administered at baseline, post-treatment, and follow-up intervals. Additionally, qualitative interviews with participants, their caregivers and clinicians will explore subjective experiences, treatment satisfaction, and perceived changes in ADHD symptoms.

This prospective cohort study will recruit 6-12 year-old children diagnosed with ADHD from pediatrics department of the third affiliated hospital of Beijing University of Chinese Medicine. Participants will be randomly assigned to two groups: an experimental group receiving acupuncture alongside traditional Chinese herbal treatment, and a control group receiving only the herbal treatment. The study will adhere to ethical guidelines, ensuring informed consent from parents and assent from children.

The research content includes three parts, as follows Phase I: Acupoint data mining for core acupoints Acupoint data mining will guide personalized treatment protocols, selecting points historically used for ADHD and supported by current research.

Phase II: Clinical Trial Intervention Quantitative assessment will involve administering the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI at baseline, post-treatment, and follow-up intervals to measure changes in ADHD symptomatology, executive function, quality of life, and sleep quality.

Phase III: Qualitative Interview Qualitative methods will complement quantitative findings, capturing subjective experiences through semi-structured interviews with children, parents, and clinicians. This approach aims to provide a holistic understanding of treatment efficacy, patient satisfaction, and perceived improvements in ADHD symptoms, executive function, quality of life, and sleep patterns.

Statistical analyses will compare SNAP-IV, Conners 3-P, BRIEF-2, PSQI and PedsQL™ 4.0 Generic Core Scales scores between groups, supplemented by thematic analysis of qualitative data to explore treatment satisfaction and symptom changes.

Statistical analyses, including paired t-tests, ANOVA, and thematic analysis, will be employed to compare outcomes between treatment groups and explore correlations between acupuncture treatment, symptom alleviation, and overall well-being measures.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Chaoyang District
      • Beijing, Chaoyang District, Chiny, 100036
        • Rekrutacyjny
        • Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 lat do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Chinese Herbal Medicine

Chinese herbal decoction based on the 2019 edition of the "Clinical Diagnosis and Treatment Guidelines for Pediatric ADHD" by the Chinese Society of Traditional Chinese Medicine.

The general treatment strategy will follow principles of clearing excess and replenishing deficiency, regulating the internal organs, and balancing yin and yang. Based on the patient's specific syndrome in TCM.

Eksperymentalny: Acupuncture

Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children.

The general treatment strategy will follow principles of clearing excess and replenishing deficiency, regulating the internal organs, and balancing yin and yang. Based on the patient's specific syndrome in TCM.

The acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
SNAP-IV
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Swanson, Nolan, and Pelham Rating Scale.

  • Items: 18 (9 inattention + 9 hyperactivity/impulsivity).
  • Response Options: 0 = Not at all, 1 = Just a little, 2 = Quite a bit, 3 = Very much.
  • Interpretation: Higher scores mean more severe ADHD symptoms (worse outcome).
From enrollment to the end of treatment at 8 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Conners 3-P
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Conners 3rd Edition-Parent Rating Scale.

  • Items: 48
  • Response Options: 0 (Not true at all) to 3 (Very much true)
  • Interpretation: Higher scores reflect more severe ADHD-related problems (worse outcome)
From enrollment to the end of treatment at 8 weeks
BRIEF-2
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Behavior Rating Inventory of Executive Function, Second Edition.

  • Items: 63
  • Response Options: 0 (Never) to 2 (Always)
  • Scoring: Raw scores are converted to T-scores; T-scores over 65 indicate a clinically elevated level
  • Interpretation: Higher T-scores denote greater executive function difficulties (worse outcome)
From enrollment to the end of treatment at 8 weeks
PedsQL 4.0 generic score
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Pediatric Quality of Life Inventory.

  • Items: 23
  • Response Options: 0 (Never), 2 (Sometimes), 4 (Always). Score Range: Original responses are transformed into a 0-100 scale
  • Interpretation: Higher scores indicate better quality of life (better outcome)
From enrollment to the end of treatment at 8 weeks
PSQI
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Pittsburgh Sleep Quality Index.

  • Items: 18 total
  • Response Options: For 14 of those items, 0 (Never), 1 (<1 time/week), 2 (2 times/week), 3 (≥3 times/week)
  • Score Range: 0-21 for the global score
  • Interpretation: Higher scores indicate poorer sleep quality (worse outcome)
From enrollment to the end of treatment at 8 weeks
VADRS
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Vanderbilt ADHD Diagnostic Rating Scale.

  • Items: 55 (ADHD core symptoms + comorbid items)
  • Response Options: 0 (Never) to 3 (Very often)
  • Interpretation: Higher scores signify more severe ADHD symptoms and comorbidity (worse outcome)
From enrollment to the end of treatment at 8 weeks
CGI
Ramy czasowe: From enrollment to the end of treatment at 8 weeks

Clinical Global Impression.

CGI-Severity (CGI-S):

  • Scale: 7 points, typically from 1 (Normal, not ill) to 7 (Among the most extremely ill)
  • Interpretation: Higher scores indicate more severe illness (worse outcome).

CGI-Improvement (CGI-I):

  • Scale: 7 points, typically from 1 (Very much improved) to 7 (Very much worse)
  • Interpretation: Lower scores indicate greater improvement, while higher scores represent worsening.
From enrollment to the end of treatment at 8 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Dyrektor Studium: Xia Cui, Ph.D.,Prof., Third Hospital of Beijing University of Chinese Medicine

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 października 2024

Zakończenie podstawowe (Szacowany)

15 grudnia 2026

Ukończenie studiów (Szacowany)

31 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

1 marca 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 marca 2025

Pierwszy wysłany (Rzeczywisty)

6 marca 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Sharing IPD is not permitted due to privacy concerns, ethical and legal restrictions, and institutional policies. Protecting minors' confidentiality and adhering to data security standards are priorities.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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