Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder

NCT03368690 | Completed

• 1 other identifier: N201706026
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

ADHD

Keywords

pine barkextract, antioxidant, ADHD, catecholamine

Outcome Measures

Primary Outcomes (5)

• Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)

  It is used to evaluate the inattention, impulsivity and hyperactivity for children and adolescent with ADHD as rated by parents and teachers. When Inattention/Hyperactivity-impulsivity subscales approach P85, the participants are going to the next steps. When subjects took Oligopin that scores decrease significantly than beseline on inattention.

  at the start of the experiment and at the 4th, 7th and 10th week

• Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)

  It is used to evaluate the inattention, impulsivity and hyperactivity for adult with ADHD as rated by participants. The scores of ASRS-V1.1 more than 17, that can be going to the next steps. When subjects took Oligopin that scores decrease significantly than beseline on impulsivity and hyperactivity.

  at the start of the experiment and at the 4th, 7th and 10th week

• Conners' Continuous Performance Test (CPT-III)

  It is used to evaluate the inattention, impulsivity and vigilance for subjects with ADHD. T-score \> 60 approach clinical standard. In the part of inattention, during supplementation of PE all sub-items were no difference when compared with baseline and sub-items of commissions were lower than placebo group (p\<0.05). Hyperactivity results were the same with part of inattention.

  at the start of the experiment and at the 4th, 7th and 10th week

• Wechsler Memory Scale , WMS-III

  Use Wechsler memory test to evaluate performance progressing in concentration and impulse control for adults Among the result of WMS, there were no significant difference in each period.

  at the start of the experiment and at the 4th, 7th and 10th week

• Wisconsin Card Sorting Test, WCST

  Use Wisconsin card test to evaluate performance progressing in concentration, impulse control for adults Among the results of WCST, there were no significantly difference between each group.

  at the start of the experiment and at the 4th, 7th and 10th week

Secondary Outcomes (8)

• Liver function

  at the start of the experiment and at the 4th, 10th week

• Kidney function

  at the start of the experiment and at the 4th, 10th week

• Lipid profile

  at the start of the experiment and at the 4th, 10th week

• Hematology

  at the start of the experiment and at the 4th, 10th week

• Iron status

  at the start of the experiment and at the 4th, 10th week

Study Arms (2)

Oligopin®

EXPERIMENTAL

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

Dietary Supplement: Oligopin®

Placebo

PLACEBO COMPARATOR

Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate )

Other: Placebo

Interventions

Oligopin® DIETARY_SUPPLEMENT

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.

Oligopin®

Placebo OTHER

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

Eligibility Criteria

• Age: 7 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children or adolescent with attention deficit hyperactivity disorder (ADHD) whose age reach 7 but under 20 and were not treated with ADHD drugs, antihypertensive drugs and dietary supplements more than 4 weeks.
• 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.

You may not qualify if:

• Children or adolescent treated with ADHD drugs, antihypertensive drugs and dietary supplements
• Adults treated with antihypertensive drugs and dietary supplements
• Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
• Autism spectrum disorder
• Intellectual disability
• Other mental disorders (e.g. Schizophrenia, Bipolar Disorder, Major depressive disorder, Anxiety Disorder, Personality disorders, Conduct disorder, Tourette Syndrome.)
• Hepatic, renal, gastrointestinal and cardiovascular disorders
• Biochemical abnormality

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (2)

Taipei Medical University - Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Taiwan Adventist Hospital

Taipei, 10556, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Oligopin

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: December 11, 2017
• Study Start: October 28, 2017
• Primary Completion: June 21, 2019
• Study Completion: August 23, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)