Safety, effectiveness, and economic evaluation of a herbal medicine, Ukgansangajinpibanha granule, in subjects with autism spectrum disorder: a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group, clinical trial

Kyung Hee University0 sites120 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 31, 2020

Last Updated

4 years ago

Study Type

Interventional Study

Sex

All

Sponsor

•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

•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