Efficacy and safety of Pediatric Huanglong Granule in children with attention deficit hyperactivity disorder: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Treatment Group:Pediatric Huanglong Granule;Control Group:Pediatric Huanglong Granule Placebo; CONDITION: Attention deficit hyperactivity disorder PRIMARY OUTCOME: Attention Deficit and Hyperactivity Disorder‐RS‐IV‐Parent:Inv; SECONDARY OUTCOME: Weiss functional impairment rating scale, parent form;Clinical Global Impression?Severity scale;Clinical Global Impressions‐Improvement;TCM syndromes scale; 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),
Epistemonikos ID: e7325f86e6d51aa0bf362a231d6814a616b41c11
First added on: Feb 20, 2024