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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Yuyu Pharma, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yuyu Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01536210
First received: January 9, 2012
Last updated: February 15, 2012
Last verified: October 2011

January 9, 2012
February 15, 2012
December 2011
August 2012   (final data collection date for primary outcome measure)
Korea-ADHD Rating scale [ Time Frame: within the first 8 weeks (plus or minus 5 days) after adminitration ] [ Designated as safety issue: No ]
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks.
Same as current
Complete list of historical versions of study NCT01536210 on ClinicalTrials.gov Archive Site
  • IOWA conner's rating scale [ Time Frame: baseline, after 2, 4, and 8 weeks ] [ Designated as safety issue: No ]
    Validated questionnaire about core ADHD symptoms(IOWA Conner's rating scale) filled out by parents at baseline, after 2,4 weeks and closeout
  • Clinical Global Impression(Severity and Improvement) [ Time Frame: baseline, after 2, 4, and 8 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout
  • Advanced Test of Attention [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline and closeout
  • children's color trails test and stroop test [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    Children's color trails test and stroop test at baseline and closeout
  • Intelligence test(from KEDI-WISC) [ Time Frame: screening and 8 weeks ] [ Designated as safety issue: No ]
    Intelligence test(from KEDI-WISC)at screening and closeout
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Mental Disorders
  • Drug: YY-162
    YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication
    Other Name: combination of Ginkgo extract and Ginseng extract
  • Drug: Placebo
    Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication
    Other Name: Placebo
  • Experimental: YY-162

    YY-162(Ginkgo Extract 30mg + Ginseng Extract 50mg)

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

    Intervention: Drug: YY-162
  • Placebo Comparator: Placebo
    Placebo 1T /Three times a day(Tid) for 8 weeks, PO medication
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2012
August 2012   (final data collection date for primary outcome measure)

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:

  • 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.
Both
6 Years to 15 Years
No
Contact: Soochurl Cho, MD,PhD 82-2-2072-3648 soochurl@snu.ac.kr
Contact: Kyeongsuk Seo, BS 82-2-2253-6600 ext 269 ksseo@yuyu.co.kr
Korea, Republic of
 
NCT01536210
YY-162 (b)
Yes
Yuyu Pharma, Inc.
Yuyu Pharma, Inc.
Not Provided
Principal Investigator: SooChurl Cho, MD, PhD Seoul National University Hospital
Principal Investigator: HyunJu Hong, MD, PhD Hallym University Hospital
Principal Investigator: EunJin Park, MD Inje University
Yuyu Pharma, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP