AcupunctureACU-ADHDNCT06860763
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
A study testing Chinese herbal medicine and Acupuncture in people with Acupuncture and ADHD - Attention Deficit Disorder With Hyperactivity, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity, Children
- What is being tested?
- Chinese herbal medicine and Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, Chaoyang District, 100036
Tananan Sangwanit, 15201052193, tananan.sangwanit@gmail.com
About this study
Official title: Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.
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.
- Conditions
- Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity, Children, Interview, Executive Functioning, Quality of Life (QOL)
- Being tested
- Chinese herbal medicine, Acupuncture
- Keywords
- Acupuncture, ADHD, Executive functioning, Interview, TCM, PedsQL
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicineDrug
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.
AcupunctureDevice
The acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Medicine | Active comparator | 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. Receives: Drug: Chinese herbal medicine |
| Acupuncture | Experimental | Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children. Receives: Drug: Chinese herbal medicine; Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
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)
Measured: From enrollment to the end of treatment at 8 weeks
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)
Measured: From enrollment to the end of treatment at 8 weeks
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)
Measured: From enrollment to the end of treatment at 8 weeks
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)
Measured: From enrollment to the end of treatment at 8 weeks
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)
Measured: From enrollment to the end of treatment at 8 weeks
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Oct 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Tananan Sangwanit, The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Investigators
- Xia Cui, Ph.D.,Prof., Study director, Third Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860763
- Sponsor's protocol ID
- BZYSY-2024YJSKTPJ-99
- Acronym
- ACU-ADHD
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 9375260Zhao 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 33610071Li 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 21056840Zhang 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 37562658Ang 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 36837594Zhou 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 26896567Wolraich 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 32111626Langberg 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 28162039Liang 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 37657199Wanni 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 36800919Danckaerts 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 19633992Groves 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 34762251Kofler 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 29705926Choi 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 36331985Anastopoulos 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT06860763
- Acronym / sponsor ID
- ACU-ADHD / BZYSY-2024YJSKTPJ-99
- Conditions
- Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity, Children, Interview, Executive Functioning, Quality of Life (QOL)
- Keywords
- Acupuncture, ADHD, Executive functioning, Interview, TCM, PedsQL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbal Medicine | Active comparator | Drug: Chinese herbal medicineChinese 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. |
| Acupuncture | Experimental | Drug: Chinese herbal medicine, Device: AcupunctureAcupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbal medicineThe 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. | Drug | Acupuncture, Chinese Herbal Medicine |
| AcupunctureThe acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques. | Device | Acupuncture |
Primary outcome
SNAP-IV
Time frame: 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).
6 secondary outcomes
Conners 3-P
Time frame: From enrollment to the end of treatment at 8 weeks
BRIEF-2
Time frame: From enrollment to the end of treatment at 8 weeks
PedsQL 4.0 generic score
Time frame: From enrollment to the end of treatment at 8 weeks
PSQI
Time frame: From enrollment to the end of treatment at 8 weeks
VADRS
Time frame: From enrollment to the end of treatment at 8 weeks
CGI
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 9375260Casebeer 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.
- Background: PubMed 33610071Zhao 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.
- Background: PubMed 21056840Li 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.
- Background: PubMed 37562658Zhang 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.
- Background: PubMed 36837594Ang 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.
- Background: PubMed 26896567Zhou 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.
- Background: PubMed 32111626Wolraich 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.
- Background: PubMed 28162039Langberg 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.
- Background: PubMed 37657199Liang 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.
- Background: PubMed 36800919Wanni 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.
- Background: PubMed 19633992Danckaerts 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.
- Background: PubMed 34762251Groves 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.
- Individual participant dataSharing planned: 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.
Related trials for Acupuncture
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Recruiting
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Metastatic Bladder Cancer, Peripheral Neuropathy
Active, not recruiting
PEACE: Comparing Chronic Pain Treatment Options
Chronic Pain, Musculoskeletal Pain
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xia Cui, Ph.D.,Prof. study director
Third Hospital of Beijing University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicine and Acupuncture in people with Acupuncture and ADHD - Attention Deficit Disorder With Hyperactivity, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tananan Sangwanit, Ph.D.student (+8615201052193, tananan.sangwanit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNAP-IV (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860763, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.