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

Primary Purpose

Mental Disorders

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

YY-162

Placebo

About this trial

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

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

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

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

Outcomes

Primary Outcome Measures

Korea-ADHD Rating scale

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

Secondary Outcome Measures

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

Clinical Global Impression(Severity and Improvement)

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

Advanced Test of Attention

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

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

NCT ID

NCT01536210

First Posted

January 9, 2012

Last Updated

February 21, 2019

Sponsor

Yuyu Pharma, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01536210

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (Actual)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

December 2012 (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

ParticipantCare ProviderInvestigator

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 1T/ Three times a day (tid) for 8 weeks, 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 patents at baseline, after 8 weeks.

Time Frame

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

Secondary Outcome Measure Information:

Title

IOWA conner's rating scale

Description

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

Title

Clinical Global Impression(Severity and Improvement)

Description

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

Title

Advanced Test of Attention

Description

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

15 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SooChurl Cho, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

HyunJu Hong, MD, PhD

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 quinquifolius 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 in Children With ADHD(Attention Deficit Hyperactivity Disorder)

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