- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100295
Herbal Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Controlled Trial of an Herbal Treatment for Juvenile Attention Deficit Hyperactivity Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Washington
-
Kenmore, Washington, United States, 98028
- Bastyr University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: B
|
300 mg given three times a day, containing rice protein powder
|
Experimental: A
Herbal treatment
|
300 mg capsule taken three times a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ADHD-IV rating scale
Time Frame: Difference between baseline and end of study
|
Difference between baseline and end of study
|
side effects scale
Time Frame: Freqency of events during entire study
|
Freqency of events during entire study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child Behavior Checklist, Youth Self Report Form
Time Frame: Baseline and end of study
|
Baseline and end of study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wendy Weber, ND, MPH, Bastyr University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23AT000929 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
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