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Trial registered on ANZCTR


Registration number
ACTRN12612000827831
Ethics application status
Approved
Date submitted
2/08/2012
Date registered
6/08/2012
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of CDRI08 (a special extract of bacopa) on children and adolescents with hyperactivity and inattention
Scientific title
The effects of CDRI08 (a special extract of bacopa) on children and adolescents with hyperactivity and inattention
Secondary ID [1] 273358 0
Nil
Universal Trial Number (UTN)
Trial acronym
KIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of Hyperactivity 279134 0
Difficulties with Attention 287098 0
Attention-Deficit/Hyperactivity Disorder 287099 0
Condition category
Condition code
Mental Health 287422 287422 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CDRI 08 (160mg capsule) Participants 20-35kg 1 capsule daily (1x morning) for 14 Weeks Participants >35kg 1 capsule twice daily (1 x morning, 1 x night) for 14 weeks
All treatments to be taken with a main meal
Intervention code [1] 283702 0
Treatment: Other
Comparator / control treatment
Participants 20-35kg 1 placebo capsule daily (1x morning) for 14 Weeks. Participants >35kg 1 placebo capsule twice daily (1 x morning, 1 x night) for 14 weeks All treatments to be taken with a main meal.
Control group
Placebo

Outcomes
Primary outcome [1] 279933 0
Level of inattention and hyperactivity:
Connors Parent Rating Scale (CPRS)
Timepoint [1] 279933 0
Practice Day (Visit 1; Week 0), Baseline (Visit 2; Week 1), Week 8 (Visit 3; Week 8); Week 15 (Visit 4; Week 15), Follow-up Visit (Visit 5; Week 16)
Secondary outcome [1] 294798 0
Cognitive Function: Test of Variables of Attention (TOVA) The CNS Vital Signs Neurocognitive online assessment (CNS VS)
Timepoint [1] 294798 0
Practice Day, Baseline, Week 8 and Week 14
Secondary outcome [2] 294799 0
Reaction Time:
Hick Reaction Time Paradigm (Jensen Box)
Timepoint [2] 294799 0
Practice Day, Baseline, Week 8 and Week 14
Secondary outcome [3] 294801 0
Neurophysiology measures:
Electroencephalogram (EEG) Resting States (Eyes open/Eyes closed)
Timepoint [3] 294801 0
Practice Day, Baseline, Week 8 and Week 14
Secondary outcome [4] 298605 0
Children's Depression Inventory (CDI)
Timepoint [4] 298605 0
Practice Day, Baseline, Week 8 and Week 14
Secondary outcome [5] 298606 0
Genetic Saliva Sampling
Timepoint [5] 298606 0
Baseline
Secondary outcome [6] 308341 0
Pediatric Sleep Problems Survey Instrument (PSPSI)
Timepoint [6] 308341 0
Practice Day
Baseline
Week 8
Week 14

Eligibility
Key inclusion criteria
Inclusion Criteria
1. Healthy non-smoking males aged between 6 and 14 years.
2. DSM-IV ADHD rating score above 15
3. Fluent or able to speak confidently in English
4. Parent/legal guardian provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
5. Participant provide a signed copy of a simplified children’s consent form
Minimum age
6 Years
Maximum age
14 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria 1. Medical diagnosis other than ADHD, Oppositional defiance disorder or similar behavioural disorder 2. Currently taking any medication (including herbal supplements (eg. Ginkgo) and stimulant medication as part of a treatment for an ADHD diagnosis) participants who are regular users (defined as daily intake for greater than 3 months) of vitamins/fish oil supplements will be asked to maintain the same habits throughout the trial 3. History of / current heart disease or high blood pressure or diabetes 4. Health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers) 6. Unable to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol 7. Does not meet minimum cut-off on WISC-IV-SF to participate in trial (<80) 8. Currently participating or having participated in another clinical trial during the last 2 months prior to beginning this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be made aware of the study via an advertisement (see attached). This advertisement will be placed, with permission, in doctors surgeries, community centres, newspapers and school newsletters. We will also be looking to contact Victorian schools via the Diocese of that school community and via the principals or board members of those schools and asking permission for publication of the advertising poster in their school newsletters and any other school media.

Potential participants (with their parent/guardian) will contact researchers in response to advertisements in order to request more information and discuss what is involved in the research. At this stage, prospective participants may be mailed or emailed a copy of the PICF. The research assistant will follow-up with prospective participants after they have had time to read all documentation. If they are still interested in taking part in the study, a telephone screen may be conducted in order to determine the eligibility of a person for the study.

A computerised random number generator will determine whether participants are allocated to treatment group a or b. This will be performed by a disinterested third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will determine whether participants are allocated to treatment group a or b. This will be performed by a disinterested third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
This is a placebo-controlled, double-blind, parallel groups, randomized trial. Conditions will follow a 2 level (placebo/CDRI 08) design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5583 0
3122

Funding & Sponsors
Funding source category [1] 284182 0
Commercial sector/Industry
Name [1] 284182 0
Soho Flordis International
Address [1] 284182 0
Sydney, Australia (Head Office)
Level 4, 156 Pacific Highway,
St Leonards NSW 2065
Country [1] 284182 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Soho Flordis International
Address
Sydney, Australia (Head Office)
Level 4, 156 Pacific Highway,
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 269138 0
None
Name [1] 269138 0
Address [1] 269138 0
Country [1] 269138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288763 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 288763 0
Level 1, Swinburne Place South
24 Wakefield Street, Hawthorn, Victoria, 3122
Ethics committee country [1] 288763 0
Australia
Date submitted for ethics approval [1] 288763 0
30/08/2012
Approval date [1] 288763 0
30/01/2013
Ethics approval number [1] 288763 0
SUHREC Project 2011/283
Ethics committee name [2] 291030 0
Royal Children's Hospital
Ethics committee address [2] 291030 0
Research Ethics & Governance
The Royal Children's Hospital
Level 2 East, Zone K
50 Flemington Road
Parkville Vic 3052
Ethics committee country [2] 291030 0
Australia
Date submitted for ethics approval [2] 291030 0
Approval date [2] 291030 0
09/12/2013
Ethics approval number [2] 291030 0
32205C

Summary
Brief summary
To examine whether 14 week administration of CDRI 08 (a special extract of bacopa) improves a range of neurophysiology, intelligence, cognitive, mood, genetic, sleep, and behavioural measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33373 0
Prof Con Stough
Address 33373 0
Mail H24, ATC Building, 427-451 Burwood Road, Swinburne University, Hawthorn, Victoria, 3122
Country 33373 0
Australia
Phone 33373 0
+61 03 9214 8167
Fax 33373 0
Email 33373 0
cstough@gmail.com
Contact person for public queries
Name 16620 0
Prof Con Stough
Address 16620 0
Mail H24, ATC Building, 427-451 Burwood Road, Swinburne University, Hawthorn, Victoria, 3122
Country 16620 0
Australia
Phone 16620 0
+61 03 9214 8167
Fax 16620 0
Email 16620 0
cstough@gmail.com
Contact person for scientific queries
Name 7548 0
Mr James Kean
Address 7548 0
Level 2, 400 Burwood Road, Hawthorn, Victoria 3122
Country 7548 0
Australia
Phone 7548 0
+61 (0)425 735 847
Fax 7548 0
Email 7548 0
jkean@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
It is anticipated that the results of this trial will be disseminated in peer reviewed journals as well as at academic conferences. All data will be collated and analysed as group data for these purposes. If requested by the publishing journal, deidentified raw data will be made available through an appropriate data repository.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary