None listed
Conditions
Interventions
Drug, Procedure/Surgery : 1. Ukgansangajinpibanha granule 1.5 g, twice/day, total 84 days, per os
2. GV20 (Backhoe), GV24 (Sinjeong), EX-HN1 (Sasinchong) Acupuncture, twice/week, total 24 times, 10-15
Sponsors
Kyung Hee University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children from 4-year-old to 6-year-old 2) Children who have received an autism spectrum disorder-specific medical certificate from the doctor (e.g. autistic disorder, Asperger’s syndrome, or pervasive developmental disorder-not otherwise specified) 3) CARS (Childhood Autism Rating Scale) score = 30 in the screening test 4) Agreement of written informed consent by sign of representative
Exclusion criteria
Exclusion criteria: 1) Hereditary syndromes including Rett syndrome, Down syndrome, or fragile X syndome 2) Other mental disorders including selective mutism, attention deficit hyperactivity disorder, schizophrenia, or depressive disorder 3) Hereditary metabolic diseases including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 4) Recently operated children, seizures including epilepsy, generalized infections needed antibiotics, brain injuries including cerebral palsy, or severe chronic or terminal illness including malignancy or tuberculosis 5) Children who have taken risperidone or aripiprazole, or less than 3 months after withdrawal 6) Children who took Korean medicine in past 1 month 7) AST, ALT, BUN, or Creatinine > three times of the normal upper limit 8) Hypersensitivity to test drug or placebo 9) Difficulty in swallowing test drug or placebo 10) Intolerance or fear of acupuncture 11) Hemostatic disorders 12) Participated another clinical trial within 1 month 13) Inappropriate to participate in the trial determined by trial director or personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Childhood Autism Rating Scale (CARS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Aberrant Behavior Checklist (ABC (2));Autism Behavior Checklist (ABC);Social Maturity Scale (SMS);Child Health Questionnaire-Parent Form 28 (CHQ-PF28);EuroQoL Five-Dimension Five-Level Youth Proxy 1 (EQ-5D-Y Proxy 1);Adverse reaction;Korean Parenting Stress Index-Short Form (K-PSI-SF) | — |
Countries
Korea, Republic of
Contacts
Public ContactSun Haeng Lee
Kyung Hee University Oriental Medical Center
Outcome results
None listed