Attention deficit hyperactivity disorder
Conditions
Interventions
Treatment Group:Pediatric Huanglong Granule
Control Group:Pediatric Huanglong Granule Placebo
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Conform to the diagnostic criteria of ADHD (clinical diagnosis by doctors) in DSM-5; 2. It conforms to the TCM syndrome differentiation standard of yin deficiency and yang hyperactivity syndrome 3. 6 years of age 14 years of age, regardless of gender 4. The total score of ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent: Inv) is >= 25 for males and >= 22 for females 5. CGI-S score >= 4 6. Both parents (guardians) and patients agree to participate in the test, and both parents (guardians) or one party and the patient need to sign an informed consent form (patients younger than 8 years old do not need to sign an informed consent form, but only make an informed notification),
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of mental disorders and need to be given psychotherapy drugs or who are judged by the investigator to have severe mental disorders that interfere with the study results 2. Patients with severe psychological and psychiatric disorders such as conduct disorder, oppositional defiant disorder, intellectual disability, neurodevelopmental disorders, childhood schizophrenia, manic episodes and bipolar disorder, and learning disabilities 3. Patients with rheumatic chorea, hepatolenticular degeneration, epileptic myoclonus, drug-induced extrapyramidal symptoms, and other extrapyramidal diseases 4. Patients with liver and(or) kidney diseases (ALT or AST >= 1.2 times the upper limit of standard value, or SCR>the upper limit of standard value); Patients with severe organic diseases such as cardiovascular, nervous system, and hematopoietic system 5. Patients who have used related psychotropic drugs for ADHD and other Chinese medicine preparations (including but not limited to Jingling Oral Liquid, Children's Intelligence Syrup, Zhibai Dihuang Pill, Qiju Dihuang Pill) and other therapies (acupuncture therapy) that have been proven by evidence-based medicine to have the effect of treating ADHD in the past 2 weeks 6. Allergies to Pediatric Huanglong Granule and excipients; Allergic constitution or allergy to multiple drugs 7. Patients who have participated in other clinical trials in recent 3 months 8. The investigator judges that the participant is not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attention Deficit and Hyperactivity Disorder-RS-IV-Parent:Inv; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weiss functional impairment rating scale, parent form;Clinical Global Impression?Severity scale;Clinical Global Impressions-Improvement;TCM syndromes scale; | — |
Countries
China
Contacts
Public ContactJunhong Wang
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed