Clinical trial for safety, effectiveness, and economic evaluation of Ukgansangajinpibanha in subjects with autism spectrum disorder

Not Applicable

Completed

• Conditions: Mental and behavioral disorders

• Registration Number: KCT0003007
• Lead Sponsor: Kyung Hee University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-31
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale (CARS)

Secondary Outcome Measures

Name	Time	Method
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)