The study is for efficacy and safety of combination of Ginkgo extract and Ginseng extract in children with ADHD(Attention Deficit Hyperactivity Disorder)

A Phase ?, Randomized, Double-Blind, Placebo-control, Dose-Finding, Efficacy and Safety of YY-162 in Patients with ADHD(Attention Deficit Hyperactivity Disorder)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000332

Enrollment

144

Registered

2012-02-01

Start date

2011-12-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental : YY-162(Ginkgo extract 30 mg + Ginseng extract 50 mg ) 1T, Three times a day(Tid)for 8 weeks, PO medication Placebo : Placebo (Ginkgo extract 00 mg + Ginseng extract 00 mg ) 1T, T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Mele and female subjects aged from 6 to 15 2. Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview 3. Subjects signed a written consent form voluntarily 4. Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian. 5. Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol. 6. Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time.

Exclusion criteria

Exclusion criteria: 1. Subjects who have difficulty swallowing tablet. 2. Subjects who have known allergy to plant extracts. 3. Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy. 4. Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder. 5. Subjects who have significant suicidal ideation. 6. Subjects with mental retardation. 7. Subjects with Tourette's syndrome requiring drug therapy. 8. Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month. 9. Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma) 10. Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology. 11. subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant. 12. subjects who receive psychosocial treatment during the drug trial. 13. Subjects who are not able to swallow the study drug.

Design outcomes

Primary

Measure	Time frame
Korea-ADHD Rating Scale(K-ARS)	—

Secondary

Measure	Time frame
IOWA Conner's rating scale ;Clinical global impression (CGI) - severity / improvement ;Advanced Test of Attention;Children's color trails test and stroop test;Intelligence test (from KEDI-WISC)	—

Countries

Korea, Republic of

Contacts

Public ContactJaewon Kim

Seoul National University Hospital

Outcome results