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

Mental Disorders Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536210
• Other study ID #: YY-162 (b)
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2019
• Source: Yuyu Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Disease
• Hyperkinesis
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• YY-162
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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Hospital	Anyang-si
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-Si
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuyu Pharma, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Korea-ADHD Rating scale	Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by patents at baseline, after 8 weeks.	within the first 8 weeks (plus or minus 5 days) after adminitration
Secondary	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	baseline, after 2, 4, and 8 weeks
Secondary	Clinical Global Impression(Severity and Improvement)	Clinical Global Impression(Severity and Improvement)rated by treating physician at baseline, after2,4 weeks and closeout	baseline, after 2, 4, and 8 weeks
Secondary	Advanced Test of Attention	Advanced Test of Attention and baseline and closeout Attention Diagnostic system(visual and auditory) at baseline and closeout	baseline and 8 weeks
Secondary	children's color trails test and stroop test	Children's color trails test and stroop test at baseline and closeout	baseline and 8 weeks
Secondary	Intelligence test(from KEDI-WISC)	Intelligence test(from KEDI-WISC)at screening and closeout	screening and 8 weeks

External Links

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