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CompletedNCT01536210ADHDUpdated Feb 25, 2019

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

A Phase 3 interventional study of YY-162 and Placebo in Mental Disorders, sponsored by Yuyu Pharma, Inc.. Completed at 3 sites in Korea, Republic of. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2019-02-25.

Sponsored by Yuyu Pharma, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
6 Years to 15 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mental Disorders

Keywords

  • ADHD(attention Deficit Hyperactivity Disorder)
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 144 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Yuyu Pharma, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

  • Subjects who have difficulty swallowing tablet.
  • Subjects who have known allergy to plant extracts.
  • Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
  • 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.
  • Subjects who have significant suicidal ideation.
  • Subjects with mental retardation.
  • Subjects with Tourette's syndrome requiring drug therapy.
  • Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
  • Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma)
  • Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology.
  • subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant.
  • subjects who receive psychosocial treatment during the drug trial.
  • Subjects who are not able to swallow the study drug.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    YY-162

    YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication

    Drug: YY-162

  • Placebo comparator
    Placebo

    Placebo 1T /Three times a day(Tid) for 8 weeks, PO medication

    Drug: Placebo

Interventions

  • DrugYY-162

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

    Also known as: combination of Ginkgo extract and Ginseng extract

  • DrugPlacebo

    Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication

06

What researchers measure

Primary outcomes

  1. Korea-ADHD Rating scale

    Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks.

    Time frame: within the first 8 weeks (plus or minus 5 days) after adminitration

Secondary outcomes

  1. IOWA conner's rating scale

    Validated questionnaire about core ADHD symptoms(IOWA Conner's rating scale) filled out by parents at baseline, after 2,4 weeks and closeout

    Time frame: baseline, after 2, 4, and 8 weeks

  2. Clinical Global Impression(Severity and Improvement)

    Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout

    Time frame: baseline, after 2, 4, and 8 weeks

  3. Advanced Test of Attention

    Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline and closeout

    Time frame: baseline and 8 weeks

  4. children's color trails test and stroop test

    Children's color trails test and stroop test at baseline and closeout

    Time frame: baseline and 8 weeks

  5. Intelligence test(from KEDI-WISC)

    Intelligence test(from KEDI-WISC)at screening and closeout

    Time frame: screening and 8 weeks

07

Study locations

3 sites
  • Hallym University Hospital
    Anyang-si, 431-070, Korea, Republic of
  • Inje University Ilsan Paik Hospital
    Goyang-Si, 411-706, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

Publications

  • Lyon MR, Cline JC, Totosy de Zepetnek J, Shan JJ, Pang P, Benishin C. Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study. J Psychiatry Neurosci. 2001 May;26(3):221-8. PubMed 11394191 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01536210
Lead sponsor
Yuyu Pharma, Inc.
Responsible party
Sponsor
First posted
Feb 20, 2012
Start date
Dec 2011
Primary completion
Aug 2012
Completion
Dec 2012
Last update
Feb 25, 2019

Study contacts

SooChurl Cho, MD, PhD
principal investigator · Seoul National University Hospital
HyunJu Hong, MD, PhD
principal investigator · Hallym University Hospital
EunJin Park, MD
principal investigator · Inje University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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