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Study on the optimisation of clinical protocols and efficacy mechanisms of Traditional Chinese Medicine in the prevention and treatment of attention deficit hyperactivity disorder in children

Study on the optimisation of clinical protocols and efficacy mechanisms of Traditional Chinese Medicine in the prevention and treatment of attention deficit hyperactivity disorder in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082223
Enrollment
Unknown
Registered
2024-03-25
Start date
2024-03-25
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Treatment group:Jingning Fang
Control group:Jingning Fang Placebo

Sponsors

Dongzhimen Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1: Meet the diagnostic criteria of Western medicine regarding attention deficit hyperactivity disorder 2: Comply with the Chinese medicine diagnostic criteria on qi and yin deficiency evidence of hyperactivity disorder in children; 3: Age =6 years old, 80 6: Parents (guardians) and children agreed to participate in the trial, and both or one of the parents (guardians) and children had to sign an informed consent form (children aged <8 years did not need to sign an informed consent form, but only to make informed notification)

Exclusion criteria

Exclusion criteria: 1: Persons with comorbid other psychiatric disorders, pervasive developmental disorders, mental retardation, and a history of suicide or self-injury (possible comorbidity with depressive disorders) need to be excluded 2: Persons with comorbidities to experimental medications, or other systemic serious illnesses 3: Exclude those with a current or recent (within 6 months prior to study entry) history of substance abuse or dependence 4: Exclusion is required for those who have had ineffective prior treatment with the test medication, or any other condition that, in the opinion of the investigator, interferes with the evaluation of the effectiveness and safety of the test medication

Design outcomes

Primary

MeasureTime frame
Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form, SNAP-IV;

Secondary

MeasureTime frame
Weiss functional impairment rating scale, parent form;The evaluation traditional Chinese medicine syndrome;Clinical Global Impression-Severity scale;Clinical Global Impressions-Improvement;liver and renal function;ECG;

Countries

China

Contacts

Public ContactWang Junhong

Dongzhimen Hospital, Beijing University of Chinese Medicine

drjhwang@bucm.edu.cn+86 10 8401 3158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026