Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Aliza Adar Levine


Contact details

108 Nachliel

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

To evaluate whether a Compound Herbal Preparation (CHP) improves attention, impulse control, and cognitive functioning in children with Attention-Deficit Hyperactivity Disorder (ADHD), Predominantly Inattentive type (ADHD-PI) and Predominantly Hyperactive-Impulsive type (ADHD-HI).

Ethics approval

Ethics approval received from the Sheba Medical Center Ethical Review Board/Israel Ministry of Health in October 2004.

Study design

A randomised, double-blind, placebo controlled trial, conducted at a single-centre (the Sheba Medical Centre).

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Attention-Deficit Hyperactivity Disorder (ADHD)


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), each comprising combined ADHD-PI, and ADHD-HI types. Participants were given a diagnosis-appropriate CHP (n = 80), or a placebo (n = 40) over a period of 4 months.

The "Compound Herbal Preparation" (CHP):
The CHP being evaluated consists of a blend of nutritive, food-grade botanicals (as approved by the Israeli Health Ministry) and prepared as a dilute ethanol extract. The Compound Herbal Preparations (CHP/CHP-H) under study are registered under the name Rikuzit ("Rikuzit"®/"Rikuzit-H"® in Israel - Hebrew for concentration), and Nurture & Clarity ("Nurture & Clarity"®/"Nurture & Clarity-H"®) internationally, and are at this time only available to Etz-HaChayim Clinic patients undergoing therapy. At this time, the CHP is not connected with any pharmaceutical or manufacturing company.

A dose of 3 ml CHP or placebo was to be taken by the participants 3 times daily, before meals, diluted in 50 - 60 ml water. The CHP or placebo was home administered by parents, and proceeded with ease throughout the study. Parents were instructed how to prepare (dilute in water) the daily dosage for the entire day. The morning, afternoon, and evening doses were administered at home before breakfast, lunch, and dinner. Alternatively, the noon/afternoon dose was taken at school.

Follow up continued for 6 months after the trial finished. All children who had received the placebo during the trial, were offered the CHP, for a period of 6 months free of charge, and subsequently monitored.

Intervention type



Not Specified

Drug names

Compound Herbal Preparation (CHP)

Primary outcome measures

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 outcome measures

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.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

One hundred and twenty children (120)

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

108 Nachliel

Sponsor information


Etz-HaChayim Clinic (Israel)

Sponsor details

5 Yodfat Street
+972 (0)9 9561178

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Etz-HaChayim Clinic (Israel)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in

Publication citations

  1. Results

    Katz M, Levine AA, Kol-Degani H, Kav-Venaki L, A compound herbal preparation (CHP) in the treatment of children with ADHD: a randomized controlled trial., J Atten Disord, 2010, 14, 3, 281-291, doi: 10.1177/1087054709356388.

Additional files

Editorial Notes