The study is for efficacy and safety of combination of Ginkgo extract and Ginseng extract in children with ADHD(Attention Deficit Hyperactivity Disorder)
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0000332
- Lead Sponsor
- Yuyu Phama
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 144
1. Mele and female subjects aged from 6 to 15
2. Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview
3. Subjects signed a written consent form voluntarily
4. Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian.
5. Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol.
6. Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time.
1. Subjects who have difficulty swallowing tablet.
2. Subjects who have known allergy to plant extracts.
3. Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
4. 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.
5. Subjects who have significant suicidal ideation.
6. Subjects with mental retardation.
7. Subjects with Tourette's syndrome requiring drug therapy.
8. Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
9. Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma)
10. Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology.
11. subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant.
12. subjects who receive psychosocial treatment during the drug trial.
13. Subjects who are not able to swallow the study drug.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Korea-ADHD Rating Scale(K-ARS)
- Secondary Outcome Measures
Name Time Method IOWA Conner's rating scale ;Clinical global impression (CGI) - severity / improvement ;Advanced Test of Attention;Children's color trails test and stroop test;Intelligence test (from KEDI-WISC)