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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10628149

Enrollment

120

Registered

2007-10-30

Start date

2004-12-10

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Attention-Deficit Hyperactivity Disorder (ADHD) Mental and Behavioural Disorders Attention-Deficit Hyperactivity Disorder

Interventions

Following assessment and diagnosis by a paediatric psychiatrist, using DSM-IV criteria, participants were randomly assigned (in 2:1 ratio) to a treatment group (n = 80) and a control group (n = 40), e

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Attention, cognitive function, and impulse control, were assessed before and after the treatment period by the 4 subscales of the Test of Variables of Attention (TOVA), as well as overall score: 1. Standard omission score 2. Standard commission score 3. Response time 4. Variability A specialised paediatric psychiatrist administered the pre-treatment TOVA. Upon completion of the 4-month participation period, each subject was reevaluated using the TOVA, with the tester, a psychology student, who was blinded as to treatment status. The two ADHD groups were pooled in analysis.	—

Measure

Time frame

Attention, cognitive function, and impulse control, were assessed before and after the treatment period by the 4 subscales of the Test of Variables of Attention (TOVA), as well as overall score: 1. Standard omission score 2. Standard commission score 3. Response time 4. Variability A specialised paediatric psychiatrist administered the pre-treatment TOVA. Upon completion of the 4-month participation period, each subject was reevaluated using the TOVA, with the tester, a psychology student, who was blinded as to treatment status. The two ADHD groups were pooled in analysis.

—

Secondary

Measure	Time frame
Detailed questionnaires, designed for the study, monitored for side effects and general state of health, and included possible adverse effects such as insomnia, stomach aches, pains, nightmares, or anxiety; as well as an evaluation of compliance with the three daily doses. Each participant and his/her parents, participated in individual meetings at 3 - 4 week intervals where the questionnaires were completed, and evaluated. Additionally, the paediatric psychiatrist conducted assessment interviews with the each participant and his/her parents twice during the trial period: midway through and at the conclusion of the trial. The questionnaires served to assess the presence of side effects, not attention or cognitive function.	—

Measure

Time frame

Detailed questionnaires, designed for the study, monitored for side effects and general state of health, and included possible adverse effects such as insomnia, stomach aches, pains, nightmares, or anxiety; as well as an evaluation of compliance with the three daily doses. Each participant and his/her parents, participated in individual meetings at 3 - 4 week intervals where the questionnaires were completed, and evaluated. Additionally, the paediatric psychiatrist conducted assessment interviews with the each participant and his/her parents twice during the trial period: midway through and at the conclusion of the trial. The questionnaires served to assess the presence of side effects, not attention or cognitive function.

—

Countries

Israel

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026