ClinicalTrials.gg
RecruitingNCT06860763ACU-ADHDUpdated Nov 4, 2026

Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.

An interventional study of Chinese herbal medicine and Acupuncture in Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity and Children, sponsored by The Third Affiliated Hospital of Beijing University of Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by The Third Affiliated Hospital of Beijing University of Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2025).
  • Started Oct 2024; still recruiting 2 years later.
Updated Nov 4, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
6 Years to 12 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 53 studies in Attention Deficit Disorder with Hyperactivity with a site in China — 18 open to participants now, 18 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · China.

Planned enrollment
15th of 44
120 · median 100
Started
2024
with 9 others
No phase
34 of 53
12 open now
Primary completion
2026-12
later than 10 of 17 live
Registered
44th of 53
by date

Among the 53 studies in Attention Deficit Disorder with Hyperactivity with a site in China, this one is the 15th largest by planned enrollment of the 44 interventional ones, is one of 10 that started in 2024, is one of 34 with no phase, reaches primary completion later than 10 of the 17 other live ones, and was the 44th registered.

By phase

53 studies; the count open now beside each. This study's row is marked.

No phasethis study34 · 12 open
Observational9 · 5 open
Phase 45 · 0 open
Phase 32 · 0 open
Phase 11 · 0 open
Phase 1/21 · 1 open
Phase 21 · 0 open

By the year they started

First in 2003; this study’s year is marked. 10 started in 2024.

Size and results

Median enrollment 100 across the 44 interventional studies, 348 across the 9 observational. Of the 26 that completed or were terminated, 4 (15%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 53 studies in Attention Deficit Disorder with Hyperactivity with a site in China, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Acupuncture
  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Children
  • Interview
  • Executive Functioning
  • Quality of Life (QOL)

Keywords

  • Acupuncture
  • ADHD
  • Executive functioning
  • Interview
  • TCM
  • PedsQL
04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients will be considered for enrolment if they meet the criteria of:

  • A confirmed diagnosis of ADHD based on the 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    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.

    Drug: Chinese herbal medicine

  • Experimental
    Acupuncture

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

    Drug: Chinese herbal medicine · Device: Acupuncture

Interventions

  • 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.

  • DeviceAcupuncture

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

06

What researchers measure

Primary outcomes

  1. SNAP-IV

    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).

    Time frame: From enrollment to the end of treatment at 8 weeks

Secondary outcomes

  1. Conners 3-P

    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)

    Time frame: From enrollment to the end of treatment at 8 weeks

  2. BRIEF-2

    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)

    Time frame: From enrollment to the end of treatment at 8 weeks

  3. PedsQL 4.0 generic score

    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)

    Time frame: From enrollment to the end of treatment at 8 weeks

  4. PSQI

    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)

    Time frame: From enrollment to the end of treatment at 8 weeks

  5. VADRS

    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)

    Time frame: From enrollment to the end of treatment at 8 weeks

  6. CGI

    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.

    Time frame: From enrollment to the end of treatment at 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
    Beijing, Chaoyang District 100036, China
    Recruiting
08

References and documents

Publications

  • Casebeer AL, Verhoef MJ. Combining qualitative and quantitative research methods: considering the possibilities for enhancing the study of chronic diseases. Chronic Dis Can. 1997;18(3):130-5. PubMed 9375260 ↗
  • Zhao FY, Fu QQ, Kennedy GA, Conduit R, Zhang WJ, Wu WZ, Zheng Z. Can acupuncture improve objective sleep indices in patients with primary insomnia? A systematic review and meta-analysis. Sleep Med. 2021 Apr;80:244-259. doi: 10.1016/j.sleep.2021.01.053. Epub 2021 Feb 2. PubMed 33610071 ↗
  • Li S, Yu B, Lin Z, Jiang S, He J, Kang L, Li W, Chen X, Wang X. Randomized-controlled study of treating attention deficit hyperactivity disorder of preschool children with combined electro-acupuncture and behavior therapy. Complement Ther Med. 2010 Oct;18(5):175-83. doi: 10.1016/j.ctim.2010.08.002. Epub 2010 Aug 30. PubMed 21056840 ↗
  • Zhang L, Huang C, Chen X, Du S, Yang J, Hu B. The efficacy of acupuncture for attention deficit hyperactivity disorder (ADHD): An overview of systematic reviews and meta-analyses. Complement Ther Med. 2023 Sep;76:102968. doi: 10.1016/j.ctim.2023.102968. Epub 2023 Aug 8. PubMed 37562658 ↗
  • Ang L, Kim JT, Kim K, Lee HW, Choi JY, Kim E, Lee MS. Acupuncture for Treating Attention Deficit Hyperactivity Disorder in Children: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2023 Feb 17;59(2):392. doi: 10.3390/medicina59020392. PubMed 36837594 ↗
  • Zhou W, Cheng X, Zhang Y. Effect of Liuwei Dihuang decoction, a traditional Chinese medicinal prescription, on the neuroendocrine immunomodulation network. Pharmacol Ther. 2016 Jun;162:170-8. doi: 10.1016/j.pharmthera.2016.02.004. Epub 2016 Feb 16. PubMed 26896567 ↗
  • Wolraich ML, Hagan JF, Allan C, et al; Subcommittee on Children and Adolescents with Attention-Deficit/Hyperactive Disorder. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144(4):e20192528. Pediatrics. 2020 Mar;145(3):e20193997. doi: 10.1542/peds.2019-3997. No abstract available. PubMed 32111626 ↗
  • Langberg JM, Molitor SJ, Oddo LE, Eadeh HM, Dvorsky MR, Becker SP. Prevalence, Patterns, and Predictors of Sleep Problems and Daytime Sleepiness in Young Adolescents With ADHD. J Atten Disord. 2020 Feb;24(4):509-523. doi: 10.1177/1087054717690810. Epub 2017 Feb 4. PubMed 28162039 ↗
  • Liang X, Qiu H, Li SX. Objectively measured sleep continuity in children and adolescents with ADHD: A systematic review and meta-analysis. Psychiatry Res. 2023 Oct;328:115447. doi: 10.1016/j.psychres.2023.115447. Epub 2023 Aug 28. PubMed 37657199 ↗
  • Wanni Arachchige Dona S, Badloe N, Sciberras E, Gold L, Coghill D, Le HND. The Impact of Childhood Attention-Deficit/Hyperactivity Disorder (ADHD) on Children's Health-Related Quality of Life: A Systematic Review and Meta-Analysis. J Atten Disord. 2023 Apr;27(6):598-611. doi: 10.1177/10870547231155438. Epub 2023 Feb 17. PubMed 36800919 ↗
  • Danckaerts M, Sonuga-Barke EJ, Banaschewski T, Buitelaar J, Dopfner M, Hollis C, Santosh P, Rothenberger A, Sergeant J, Steinhausen HC, Taylor E, Zuddas A, Coghill D. The quality of life of children with attention deficit/hyperactivity disorder: a systematic review. Eur Child Adolesc Psychiatry. 2010 Feb;19(2):83-105. doi: 10.1007/s00787-009-0046-3. Epub 2009 Jul 26. PubMed 19633992 ↗
  • Groves NB, Wells EL, Soto EF, Marsh CL, Jaisle EM, Harvey TK, Kofler MJ. Executive Functioning and Emotion Regulation in Children with and without ADHD. Res Child Adolesc Psychopathol. 2022 Jun;50(6):721-735. doi: 10.1007/s10802-021-00883-0. Epub 2021 Nov 11. PubMed 34762251 ↗
  • Kofler MJ, Irwin LN, Soto EF, Groves NB, Harmon SL, Sarver DE. Executive Functioning Heterogeneity in Pediatric ADHD. J Abnorm Child Psychol. 2019 Feb;47(2):273-286. doi: 10.1007/s10802-018-0438-2. PubMed 29705926 ↗
  • Choi WS, Woo YS, Wang SM, Lim HK, Bahk WM. The prevalence of psychiatric comorbidities in adult ADHD compared with non-ADHD populations: A systematic literature review. PLoS One. 2022 Nov 4;17(11):e0277175. doi: 10.1371/journal.pone.0277175. eCollection 2022. PubMed 36331985 ↗
  • Anastopoulos AD, DuPaul GJ, Weyandt LL, Morrissey-Kane E, Sommer JL, Rhoads LH, Murphy KR, Gormley MJ, Gudmundsdottir BG. Rates and Patterns of Comorbidity Among First-Year College Students With ADHD. J Clin Child Adolesc Psychol. 2018 Mar-Apr;47(2):236-247. doi: 10.1080/15374416.2015.1105137. Epub 2016 Feb 6. PubMed 26852645 ↗
  • Danielson ML, Bitsko RH, Ghandour RM, Holbrook JR, Kogan MD, Blumberg SJ. Prevalence of Parent-Reported ADHD Diagnosis and Associated Treatment Among U.S. Children and Adolescents, 2016. J Clin Child Adolesc Psychol. 2018 Mar-Apr;47(2):199-212. doi: 10.1080/15374416.2017.1417860. Epub 2018 Jan 24. PubMed 29363986 ↗
  • Li F, Cui Y, Li Y, Guo L, Ke X, Liu J, Luo X, Zheng Y, Leckman JF. Prevalence of mental disorders in school children and adolescents in China: diagnostic data from detailed clinical assessments of 17,524 individuals. J Child Psychol Psychiatry. 2022 Jan;63(1):34-46. doi: 10.1111/jcpp.13445. Epub 2021 May 21. PubMed 34019305 ↗
  • Simon V, Czobor P, Balint S, Meszaros A, Bitter I. Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis. Br J Psychiatry. 2009 Mar;194(3):204-11. doi: 10.1192/bjp.bp.107.048827. PubMed 19252145 ↗
  • Gao Q, Qian Y, He XX, Sun L, Chang WL, Li YL, Cao QJ, Wang YF, Qian QJ. Childhood predictors of persistent ADHD in early adulthood: Results from the first follow-up study in China. Psychiatry Res. 2015 Dec 30;230(3):905-12. doi: 10.1016/j.psychres.2015.11.025. Epub 2015 Nov 17. PubMed 26614011 ↗

Individual participant data

Plan to share: No — 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.

Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 26 months is close to that.

Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Oct 2026 → Dec 2026 and completion Jan 2027 → Mar 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2025
First posted
Mar 6, 2025
StartActual
Oct 15, 2024
Primary completionEst.
Dec 15, 2026was Oct 2026
CompletionEst.
Mar 31, 2027was Jan 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Oct 15, 2026→Dec 15, 2026
Nov 4, 2026
Study completion
Jan 31, 2027→Mar 31, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Primary completion Oct 15, 2026→Dec 15, 2026
    Study completion Jan 31, 2027→Mar 31, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06860763
Lead sponsor
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Collaborators
Mahidol University
Responsible party
Tananan Sangwanit (Principal Investigator (PI), The Third Affiliated Hospital of Beijing University of Chinese Medicine) — Principal investigator
First posted
Mar 6, 2025
Start date
Oct 15, 2024
Primary completion
Dec 15, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Tananan Sangwanit, Ph.D.student
Contact
tananan.sangwanit@gmail.com
+8615201052193
Xue Bai, Ph.D.
Contact
baixue8912@163.com
+8618810212203
Xia Cui, Ph.D.,Prof.
study director · Third Hospital of Beijing University of Chinese Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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