Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder
NCT ID: NCT03368690
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-10-28
2019-08-23
Brief Summary
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Detailed Description
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20 children and adolescent aged above 7 but under 20 years old and 20 adults aged from 20 to 65 years old with ADHD will be enrolled in this randomized, double-blind, cross-over and placebo controlled 10-weeks period experiment.
At the treatment period (0th to 4th week of the experiment), children and adolescent with ADHD will receive 1\~2 placebo or capsules of polyphenolic extract from pine bark (25mg Oligopin per capsule) according to their body weight. On the other hand, adult with ADHD will receive 2\~3 placebo or capsules of polyphenolic extract from pine bark (50mg Oligopin per capsule). The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment. Psychiatric examination and nutrition status evaluation will be carried out in this study. At the beginning, 4th, 7th and 10th week of the study, basic psychiatric examination will be carried out by clinical psychologist. Routine laboratory parameter including liver function, kidney function, lipid profile, antioxidative status and iron status will be investigated at the beginning, 4th and 10th week of the study. The nutrition status evaluation including food frequency questionnaire and three-day dietary record (two days on weekdays, one day on holiday). The food frequency questionnaire will be performed at the beginning, 4th, 7th and 10th of the experiment while three-day dietary record will be performed at 2th, 4th , 8th and 10th of the experiment. We expect that polyphenolic extract from pine bark may improve oxidative status which in turn ameliorate the attention and emotional stability in patients with ADHD.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Oligopin®
Dietary supplement, Polyphenolic extract from pine bark. This group receives a nutritional supplement for a period of 10 weeks.
Children and adolescent 20-50 kg body weight: 25 mg Oligopin®/day; \> 50 kg body weight: 50 mg Oligopin®/day Adults 40-60 kg body weight: 100 mg Oligopin®/day; \> 60 kg body weight: 150 mg Oligopin®/day
Oligopin®
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1\~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
Placebo
Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate )
Placebo
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1\~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
Interventions
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Oligopin®
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1\~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
Placebo
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1\~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
Eligibility Criteria
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Inclusion Criteria
2. Adults with attention deficit hyperactivity disorder (ADHD) aged from 20 to 65 and were not treated with antihypertensive drugs and dietary supplements more than 4 weeks.
Exclusion Criteria
2. Adults treated with antihypertensive drugs and dietary supplements
3. Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
4. Autism spectrum disorder
5. Intellectual disability
6. Other mental disorders (e.g. Schizophrenia, Bipolar Disorder, Major depressive disorder, Anxiety Disorder, Personality disorders, Conduct disorder, Tourette Syndrome.)
7. Hepatic, renal, gastrointestinal and cardiovascular disorders
8. Biochemical abnormality
7 Years
64 Years
ALL
No
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Locations
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Taipei Medical University - Shuang Ho Hospital
New Taipei City, , Taiwan
Taiwan Adventist Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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N201706026
Identifier Type: -
Identifier Source: org_study_id
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