search
Back to results

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

Primary Purpose

Mental Disorders

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YY-162
Placebo
Sponsored by
Yuyu Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring ADHD(Attention Deficit Hyperactivity Disorder)

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged from 6 to 12
  • 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.

Sites / Locations

  • Hallym University Hospital
  • Inje University Ilsan Paik Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

YY-162

Placebo

Arm Description

YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication

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

Outcomes

Primary Outcome Measures

Korea-ADHD Rating scale
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.

Secondary Outcome Measures

IOWA Conner's rating scale
Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout
Clinical global Impression(Severity and Improvement)
Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout
Advanced Test of Attention
Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout
Children's color trails test and stroop test
Children's color trails test and stroop test at baseline and closeout
Intelligence test(from KEDI-WISC)
Intelligence test(from KEDI-WISC) at screening and closeout

Full Information

First Posted
September 12, 2010
Last Updated
February 21, 2019
Sponsor
Yuyu Pharma, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01201187
Brief Title
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD
Acronym
yuyu
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuyu Pharma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
ADHD(Attention Deficit Hyperactivity Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YY-162
Arm Type
Experimental
Arm Description
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1T/twice a day(bid) for 8weeks, po medication
Intervention Type
Drug
Intervention Name(s)
YY-162
Other Intervention Name(s)
Combination of Ginkgo extract and Ginseng extract
Intervention Description
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1T/twice a day(bid) for 8weeks, po medication
Primary Outcome Measure Information:
Title
Korea-ADHD Rating scale
Description
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.
Time Frame
from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
IOWA Conner's rating scale
Description
Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout
Time Frame
from baseline from 8 weeks
Title
Clinical global Impression(Severity and Improvement)
Description
Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout
Time Frame
from baseline to 8 weeks
Title
Advanced Test of Attention
Description
Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout
Time Frame
baseline and 8 weeks
Title
Children's color trails test and stroop test
Description
Children's color trails test and stroop test at baseline and closeout
Time Frame
baseline and 8 weeks
Title
Intelligence test(from KEDI-WISC)
Description
Intelligence test(from KEDI-WISC) at screening and closeout
Time Frame
screening and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged from 6 to 12 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo-Churl Cho, MD, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyun Ju Hong, MD,Ph.D
Organizational Affiliation
Hallym University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EunJin Park, MD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Hospital
City
Anyang-si
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang-Si
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
11394191
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study.

Learn more about this trial

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

We'll reach out to this number within 24 hrs