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

NCT ID: NCT01536210

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

YY-162

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

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

Group Type: EXPERIMENTAL

YY-162

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

YY-162

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

combination of Ginkgo extract and Ginseng extract

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuyu Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SooChurl Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

HyunJu Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Hospital

EunJin Park, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

Hallym University Hospital

Anyang-si, , South Korea

Inje University Ilsan Paik Hospital

Goyang-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 11394191 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed

Effect of the herbal extract combination Panax quinquifolius and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study

Other Identifiers

YY-162 (b)

Identifier Type: -

Identifier Source: org_study_id