Pycnogenol
Dietary SupplementDietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
NCT Number: NCT02700685
This double blind, randomised controlled trial examines the effect of a commercially available nutritional supplement on behaviour of ADHD patients, as well as on their physical and psychiatric co-morbidities, and level of oxidative stress and immune activity, as compared to placebo and standard pharmaceutical treatment for ADHD.
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Notify Me6 year–12 year
All sexes
Interventional
Phase 3
Universitaire Kinder- en Jeugdpsychiatrie, Borgerhout, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
Standard pharmaceutical treatment for ADHD, slow release.
Placebo treatment (identical capsules containing excipients only)
Time frame: 10 weeks
Time frame: 5 weeks
Time frame: 5 weeks, 10 weeks
Time frame: 10 weeks
Time frame: 5 & 10 weeks
Time frame: 5 & 10 weeks
Time frame: 5 & 10 weeks
Score reduction of at least 20% for parents and/or teachers
Time frame: 5 & 10 weeks
Score reduction of at least 20% for parents and/or teachers
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 5 & 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 10 weeks
Percentage of participants with side effects, treatment adherence and proportion of drop-outs
Time frame: 10 weeks
Percentage of participants with side effects
Time frame: 10 weeks
Proportion of drop-outs
Time frame: 10 weeks
Treatment adherence
Time frame: 10 weeks
Time frame: 10 weeks
Time frame: 6 months
Long-term follow up on eventual treatment choice (medication, no intervention, nutritional supplement)
Time frame: 6 months
Long-term follow up on behaviour
Time frame: 6 months
Long-term follow up on physical/psychiatric complaints
Nina Hermans
Other
Effect of a Polyphenol-rich Plant Extract on Attention-Deficit Hyperactivity Disorder (ADHD): A Randomized, Double Blind, Placebo and Active Product Controlled Multicenter Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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