None listed
Conditions
Brief summary
To examine whether 14 week administration of CDRI 08 (a special extract of bacopa) improves a range of neurophysiology, intelligence, cognitive, mood, genetic, sleep, and behavioural measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo.
Interventions
CDRI 08 (160mg capsule) Participants 20-35kg 1 capsule daily (1x morning) for 14 Weeks Participants >35kg 1 capsule twice daily (1 x morning, 1 x night) for 14 weeks
All treatments to be taken with a main meal
Sponsors
Soho Flordis International
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria 1. Healthy non-smoking males aged between 6 and 14 years. 2. DSM-IV ADHD rating score above 15 3. Fluent or able to speak confidently in English 4. Parent/legal guardian provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial. 5. Participant provide a signed copy of a simplified children’s consent form
Exclusion criteria
Exclusion Criteria 1. Medical diagnosis other than ADHD, Oppositional defiance disorder or similar behavioural disorder 2. Currently taking any medication (including herbal supplements (eg. Ginkgo) and stimulant medication as part of a treatment for an ADHD diagnosis) participants who are regular users (defined as daily intake for greater than 3 months) of vitamins/fish oil supplements will be asked to maintain the same habits throughout the trial 3. History of / current heart disease or high blood pressure or diabetes 4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers) 6. Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol 7. Does not meet minimum cut-off on WISC-IV-SF to participate in trial (<80) 8. Currently participating or having participated in another clinical trial during the last 2 months prior to beginning this study.
Outcome results
None listed