NCT01201187

Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD

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 – 12 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/twice a day(bid) for 8weeks, po medication
DRUG	Placebo	Placebo 1T/twice a day(bid) for 8weeks, po medication

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-04-01
• Completion: 2011-04-01
• First posted: 2010-09-14
• Last updated: 2019-02-25

Locations

3 sites across 1 country: South Korea