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This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YY-162 | Experimental | YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication |
|
| Placebo | Placebo Comparator | Placebo 1T/twice a day(bid) for 8weeks, po medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YY-162 | Drug | YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline from 8 weeks |
| Clinical global Impression(Severity and Improvement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Churl Cho, MD, Ph.D | Seoul National University Hospital | Principal Investigator |
| Hyun Ju Hong, MD,Ph.D | Hallym University Hospital | Principal Investigator |
| EunJin Park, MD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Hospital | Anyang-si | 431-070 | South Korea | |||
| Inje University Ilsan Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11394191 | Result | 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. |
| Label | URL |
|---|---|
| Effect of the herbal extract combination Panax quinquefolium and Ginkgo biloba on attention-deficit hyperactivity disorder: a pilot study. | View source |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| C000592553 | YY162 |
| C000713447 | Asian ginseng |
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| Placebo | Drug | Placebo 1T/twice a day(bid) for 8weeks, po medication |
|
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 | 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 | Children's color trails test and stroop test at baseline and closeout | baseline and 8 weeks |
| Intelligence test(from KEDI-WISC) | Intelligence test(from KEDI-WISC) at screening and closeout | screening and 8 weeks |
| Goyang-si |
| 411-706 |
| South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |