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Trial registered on ANZCTR


Registration number
ACTRN12615000790549
Ethics application status
Approved
Date submitted
18/07/2015
Date registered
30/07/2015
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Curcumin for the treatment of attention deficit hyperactivity disorder (ADHD) - a randomised, double-blind, placebo-controlled study
Scientific title
Curcumin for the treatment of attention deficit hyperactivity disorder (ADHD) - a randomised, double-blind, placebo-controlled study
Secondary ID [1] 286550 0
Nil
Universal Trial Number (UTN)
U1111-1169-3930
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder (ADHD) 294798 0
Condition category
Condition code
Mental Health 295074 295074 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Curcumin capsules containing 250-500mg of a proprietary blend of curcumin (BCM-95 'Registered Trademark') will be consumed twice daily for 12 weeks by children diagnosed with ADHD or with significant attentional problems. Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 291657 0
Treatment: Other
Comparator / control treatment
Placebo, is matched to to the curcumin capsules in terms of taste and appearance, but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 294836 0
Change in ADHD score as assessed by the ADHD Rating Scale-IV
Timepoint [1] 294836 0
Weeks 0, 4, 8 and 12
Secondary outcome [1] 314180 0
Strengths and Difficulties Questionnaire (SDQ). The SDQ is a behavioral screening questionnaire assessing the following areas- emotional symptoms, conduct problems, hyperactivity/ inattention, peer relationship problems and prosocial behaviour.
Timepoint [1] 314180 0
Weeks 0, 4, 8 and 12

Eligibility
Key inclusion criteria
1. Child is a healthy male or female aged between 6 and 14 years
2. Child has been diagnosed with ADHD or significant attentional problem, as assessed by investigators
3. Child is willing and able to swallow capsules.
4. Preferable, but not essential. Child’s teacher is willing to complete questionnaires (at the beginning and end of the study)
Minimum age
6 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or 12-month history in your child of any psychiatric disorder other than ADHD, oppositional defiant disorder or similar behavioural disorder (moderate-to-high severity).
2. Child is currently taking any pharmaceutical medication (including ADHD medication), apart from the occasional use (no more than fortnightly) of pain-relievers (e.g., ibuprofen, panadeine).
3. Child is currently taking turmeric/ curcumin supplements and/or other specific herbal products
4. Child has current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes
5. Child currently abuses or is dependent on drugs
6. Child has any learning problem significantly affecting his/her educational achievement

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)
Participants will respond to advertisements. Participants will then be briefly interviewed to assess eligibility and if meeting eligibility criteria a formal mental health assessment will be conducted (MINI International Neuropsychiatric interview). If the participant meets all eligibility criteria, he/she will be randomly allocated into a placebo or curcumin treatment group. Group allocation will be conducted in a double-blind, randomised fashion. Allocation concealment will occur through the use of numbered containers where both the participant, and primary researcher responsible for conducting the study, will be unaware of its contents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 60) based on order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 60 into either group 1 or 2.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
As this is the first time curcumin will be used for the treatment of ADHD the magnitude of treatment effects from curcumin is not known. However, in a previous study using another natural substance (Pinus marinus) positive effects were found when a sample size of 60 children was used. In this study a moderate effect size of 0.75 for the treatment group was identified. Assuming a power of 80% and a type one error rate (alpha) of 5%, the number of participants per group to find an effect is 29. In the current study we will be using 30 participants per group

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)
WA

Funding & Sponsors
Funding source category [1] 291115 0
Commercial sector/Industry
Name [1] 291115 0
Dolcas-Biotech, LLC
Address [1] 291115 0
29 Beacon Hill Drive
Chester, NJ 07930
Country [1] 291115 0
United States of America
Primary sponsor type
University
Name
Murdoch University
Address
90 South St
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 289791 0
None
Name [1] 289791 0
Address [1] 289791 0
Country [1] 289791 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292696 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 292696 0
90 South St
Murdoch WA 6150
Ethics committee country [1] 292696 0
Australia
Date submitted for ethics approval [1] 292696 0
Approval date [1] 292696 0
01/04/2015
Ethics approval number [1] 292696 0
2015/002

Summary
Brief summary
This is a double-blind, placebo controlled study assessing the therapuetic effects of curcumin in 60 youth suffering from ADHD or significant attentional problem. Participants will be randomly allocated into either a curcumin (BCM-95 'Registered Trademark' - 250-500mg twice daily) or placebo group and changes in ADHD symptoms and general behaviour will be measured over a 12-week period.
Trial website
Trial related presentations / publications
No publication has been submitted.
Public notes

Contacts
Principal investigator
Name 56614 0
Prof Peter Drummond
Address 56614 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56614 0
Australia
Phone 56614 0
+61 8 9360 2415
Fax 56614 0
Email 56614 0
P.Drummond@murdoch.edu.au
Contact person for public queries
Name 56615 0
Dr Adrian Lopresti
Address 56615 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56615 0
Australia
Phone 56615 0
+61411969797
Fax 56615 0
Email 56615 0
a.lopresti@murdoch.edu.au
Contact person for scientific queries
Name 56616 0
Dr Adrian Lopresti
Address 56616 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 56616 0
Australia
Phone 56616 0
+61411969797
Fax 56616 0
Email 56616 0
a.lopresti@murdoch.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary