NCT01536210

Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)

Randomized, Double-Blind, Placebo-control, Multicenter Study, the Efficacy and Safety of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD(Attention Deficit Hyperactivity Disorder)in 8 Weeks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Yuyu Pharma, Inc. · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.

Detailed description

This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract)in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2, 4 and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA conner's rating scale, CGI-S/I, ATA, Children's color trails test and stroop test, intelligence test(from KEDI-WISC)and adverse event reporting.

Conditions

• Mental Disorders

Interventions

Type	Name	Description
DRUG	YY-162	YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication
DRUG	Placebo	Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2012-02-20
• Last updated: 2019-02-25

Locations

3 sites across 1 country: South Korea