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)
| ISRCTN | ISRCTN10628149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10628149 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/10/2007
- Registration date
- 30/10/2007
- Last edited
- 18/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Aliza Adar Levine
Scientific
Scientific
108 Nachliel
DnModin
71938
Israel
Study information
| Study design | A randomised, double-blind, placebo controlled trial, conducted at a single-centre (the Sheba Medical Centre). |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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(s) | Ethics approval received from the Sheba Medical Center Ethical Review Board/Israel Ministry of Health in October 2004. |
| Condition | Attention-Deficit Hyperactivity Disorder (ADHD) |
| Intervention | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Compound Herbal Preparation (CHP) |
| Primary outcome measure | 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 study start date | 10/12/2004 |
| Overall study end date | 20/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | One hundred and twenty children (120) |
| 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 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 | 10/12/2004 |
| Recruitment end date | 20/03/2006 |
Locations
Countries of recruitment
- Israel
Study participating centre
108 Nachliel
DnModin
71938
Israel
71938
Israel
Sponsor information
Etz-HaChayim Clinic (Israel)
Hospital/treatment centre
Hospital/treatment centre
5 Yodfat Street
Herzliya
46583
Israel
| Phone | +972 (0)9 9561178 |
|---|---|
| kavenaki@bezeqint.net |
Funders
Funder type
Hospital/treatment centre
Etz-HaChayim Clinic (Israel)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No |
