Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder
Condition: ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      In this study, the investigators will investigate the effects of polyphenolic extract from
      pine bark on the inattention and hyperactivity in patients with attention deficit
      hyperactivity disorder (ADHD) based on antioxidative status.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by
      developmentally inappropriate levels of impulsive behavior, hyperactivity and/or inattention.
      It is one of the most prevalent chronic pediatric neurodevelopmental conditions. The
      pathology of ADHD may relate to the oxidative stress caused by abnormal neurotransmitters.
      Therefore, we would like to intervene pine bark extract (PE) which can improve the symptom of
      inattention and hyperactivity from the psychological assessment and antioxidative status.

      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.
    

Intervention name(s): Oligopin®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pine barkextract, antioxidant, ADHD, catecholamine