A randomised, double-blind, placebo-controlled clinical trial of a Compound Herbal Preparation (CHP) in the treatment of children with Attention-Deficit Hyperactivity Disorder (ADHD)

Completed

• Conditions: Attention-Deficit Hyperactivity Disorder (ADHD); Mental and Behavioural Disorders; Attention-Deficit Hyperactivity Disorder

• Registration Number: ISRCTN10628149
• Lead Sponsor: Etz-HaChayim Clinic (Israel)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. One hundred and twenty children, aged 6 - 12 years
2. Recruited from the Sheba Medical Center Clinic for Paediatric Behavioural Disorders
3. No history of prior treatment for ADHD
4. Diagnosed with ADHD-PI or ADHD-H by a specialised paediatric psychiatrist, based on Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria and assessment interviews with participants and their parents
5. Children meeting the DSM-IV criteria for inclusion in the study were evaluated with the Test of Variables of Attention (TOVA). Inclusion required a standard score of below 85 on at least one of the TOVA subscales

Exclusion Criteria

1. Medical conditions, other than ADHD, causing inattention and hyperactivity (i.e., anaemia, hypoglycaemia, thyroid disorders, etc.)
2. A standard score of over 85 on all of the TOVA (Test of Variables of Attention) subscales

Study & Design

• Study Type: Interventional
• Study Design: Not specified