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Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00100295
Enrollment
59
Registered
2004-12-29
Start date
2005-02-28
Completion date
2006-11-30
Last updated
2007-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Adolescent, Child, Phytotherapy

Brief summary

The purpose of this study is to determine the safety and effectiveness of an herbal product for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents.

Detailed description

ADHD is a common childhood disorder associated with concentration problems and disruptive behavior. Evidence suggests that herbal remedies may be as effective as standard drug therapies in treating ADHD symptoms. This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD. This study will last 9 weeks. Participants will be randomly assigned to receive either an herbal product or placebo three times a day for the duration of the study. Participants will come in for weekly study visits at which their ADHD symptoms and any side effects will be assessed by self-report rating scales.

Interventions

300 mg capsule taken three times a day

OTHERPlacebo

300 mg given three times a day, containing rice protein powder

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of ADHD * Score of greater than 1.5 standard deviation above the age and gender norms on the ADHD-IV rating scale * Parents and children can understand English * Parents and children willing to attend all study visits * Able to swallow study medication * Willing to use acceptable methods of contraception

Exclusion criteria

* Severe depression * History of bipolar disorder, psychosis, severe conduct disorder, or other serious medical conditions * Use of medications that may interact with the herbal product * Current use of medications to treat ADHD * Previous use of Hypericum * Pregnancy

Design outcomes

Primary

MeasureTime frame
side effects scaleFreqency of events during entire study
ADHD-IV rating scaleDifference between baseline and end of study

Secondary

MeasureTime frame
Child Behavior Checklist, Youth Self Report FormBaseline and end of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026