Omega-3/Ginseng-Combined Supplementation, in Children with Subthreshold Attention-Deficit Hyperactivity Disorder

Efficacy of “Smart Balance,” an Omega-3/Ginseng-combined supplementation, in Children with Subthreshold Attention-Deficit Hyperactivity Disorder: Double-blind, Randomized, Placebo-controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003796

Enrollment

120

Registered

2019-04-16

Start date

2019-04-11

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : After an initial screening visit, subjects meeting inclusion and exclusion criteria would be randomized 1:1 to either the omega-3/ginseng group or the placebo group. A computer-ge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? School-aged Children between 6 to 12 years ? Voluntary participation ? Informed consent and assent from both the participant and his/her parent ? Able to follow study protocol ? Subthreshold ADHD: 3~5 Inattentive symptoms or/and 3~5 Hyperactivity/Impulsivity symptoms according to DSM-5 ADHD diagnostic criteria

Exclusion criteria

Exclusion criteria: ? Intellectual disability, Autism spectrum disorder, ADHD ? Major depressive disorder, bipolar disorder, psychotic disorder, tourette's syndrome, obsessive-compulsive disorder, posttraumatic stress disorder ? organic brain damage, epilepsy, or neurologic disorders ? ongoing chronic medical conditions ? Consumption of psychotic drugs that could affect the CNS symtpom during the last 3 months ? Able to swallow pills

Design outcomes

Primary

Measure	Time frame
ADHD rating scale	—

Secondary

Measure	Time frame
Child Behavior Checklist;Advanced Test of Attention;Auditory Verbal Learning Test;Stroop Test;Children's Color Trails Test	—

Countries

Korea, Republic of

Contacts

Public ContactJeewon Lee

Soon Chun Hyang University Hospital Bucheon

etamjung@hanmail.net+82-32-621-6262

Outcome results