- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201187
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract(YY-162)in Children With ADHD (yuyu)
February 21, 2019 updated by: Yuyu Pharma, Inc.
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Anyang-si, Korea, Republic of, 431-070
- Hallym University Hospital
-
Goyang-Si, Korea, Republic of, 411-706
- Inje University Ilsan Paik Hospital
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YY-162
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
|
YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
Other Names:
|
Placebo Comparator: Placebo
Placebo 1T/twice a day(bid) for 8weeks, po medication
|
Placebo 1T/twice a day(bid) for 8weeks, po medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Korea-ADHD Rating scale
Time Frame: from baseline to 8 weeks
|
Validated questionnaire about core ADHD symptoms(Korea-ADHD Rating scale) filled out by parents at baseline, after 2,4 and 8 weeks.
|
from baseline to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOWA Conner's rating scale
Time Frame: from baseline from 8 weeks
|
Validated questionnaire about core ADHD symptoms(IOWA Conner's ration scale) filled out by parents at baseline, after 2,4 weeks and closeout
|
from baseline from 8 weeks
|
Clinical global Impression(Severity and Improvement)
Time Frame: from baseline to 8 weeks
|
Clinical global Impression(Severity and Improvement) rated by treating physician at baseline, after 2,4 weeks and closeout
|
from baseline to 8 weeks
|
Advanced Test of Attention
Time Frame: baseline and 8 weeks
|
Advanced Test of Attention at baseline and closeout Attention Diagnostic system (visual and auditory) at baseliner and closeout
|
baseline and 8 weeks
|
Children's color trails test and stroop test
Time Frame: baseline and 8 weeks
|
Children's color trails test and stroop test at baseline and closeout
|
baseline and 8 weeks
|
Intelligence test(from KEDI-WISC)
Time Frame: screening and 8 weeks
|
Intelligence test(from KEDI-WISC) at screening and closeout
|
screening and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: EunJin Park, MD, Inje University
- Principal Investigator: Soo-Churl Cho, MD, Ph.D, Seoul National University Hospital
- Principal Investigator: Hyun Ju Hong, MD,Ph.D, Hallym University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
September 12, 2010
First Submitted That Met QC Criteria
September 12, 2010
First Posted (Estimate)
September 14, 2010
Study Record Updates
Last Update Posted (Actual)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YY-162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Disorders
-
Kansas State UniversityAugusta University; Dartmouth College; University of CincinnatiEnrolling by invitationMental Disorders, Severe | Mental Illness PersistentUnited States
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
University of ManchesterEuropean Research CouncilRecruitingMental Disorders, SevereUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Active, not recruitingMental Disorders, SevereSpain
-
University of North Carolina, Chapel HillU.S. Department of JusticeCompletedMental Disorders, SevereUnited States
-
Liga Romana pentru Sanatate MintalaPsychiatric Hospital for Chronic Patients Siret, Suceava, RomaniaUnknown
Clinical Trials on YY-162
-
Yuyu Pharma, Inc.Completed
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownMantle Cell Lymphoma | Marginal Zone Lymphoma | Lymphoplasmacytic Lymphoma | Diffuse Large B Cell Lymphoma | Small Lymphocytic Lymphoma
-
Yuyu Pharma, Inc.CompletedDiabetesKorea, Republic of
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownRelapsed or Refractory Peripheral T-Cell LymphomaChina
-
Shanghai YingLi Pharmaceutical Co. Ltd.Not yet recruiting
-
Shanghai YingLi Pharmaceutical Co. Ltd.Not yet recruitingIndolent B-cell Lymphoma
-
Ruijin HospitalTianjin Medical University Cancer Institute and HospitalNot yet recruitingFocus on the Lymphoma Including B/T-cell LymphomaChina
-
Shanghai YingLi Pharmaceutical Co. Ltd.Not yet recruitingEffectiveness,Safety,Thymic Cancer
-
Shanghai YingLi Pharmaceutical Co. Ltd.UnknownLymphoma, FollicularChina
-
Shanghai YingLi Pharmaceutical Co. Ltd.RecruitingPeripheral T/NK Cell Lymphoma (R/R PTCL)United States