Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000656831
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
31/05/2021
Date last updated
28/03/2022
Date data sharing statement initially provided
31/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an ashwagandha extract (KSM-66) on memory, attention, energy, and sleep in children
Scientific title
Effects of an ashwagandha extract (KSM-66) on memory, attention, energy, and sleep in children: a randomised, double-blind, placebo-controlled, multi-national study
Secondary ID [1] 304116 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 321799 0
Sleep 321800 0
Energy 321801 0
Condition category
Condition code
Alternative and Complementary Medicine 319525 319525 0 0
Herbal remedies
Mental Health 319526 319526 0 0
Other mental health disorders
Neurological 319527 319527 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ashwagandha extract (KSM-66) (1 gummy taken orally, twice daily with breakfast and dinner, delivering 300 mg a day for 8 weeks)

Adherence to gummy intake will be monitored through a mobile phone app and gummy return and count.
Intervention code [1] 320451 0
Treatment: Other
Comparator / control treatment
Placebo (containing pectin and honey) is matched to the ashwagandha extract gummies in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 327395 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 327395 0
Day 0 and week 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 394913 0
Change in the Behavior Rating Inventory of Executive Function, 2nd Ed (BRIEF2) (Parent version)
Timepoint [1] 394913 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [2] 394914 0
Change in the Strength and Difficulties Questionnaire (SDQ), Parent Version
Timepoint [2] 394914 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [3] 394915 0
Change in the Sleep Disturbance Scale for Children
Timepoint [3] 394915 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [4] 394916 0
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Timepoint [4] 394916 0
Day 0, weeks 4, & 8 post-intervention commencement

Eligibility
Key inclusion criteria
1. Parent-reported concerns in child’s attention, concentration, or memory
2. Child attends mainstream schooling and mainstream classing
3. Child is a healthy male or female aged between 6 and 12 years
4. Parent/legal guardian and child willing to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
5. Child willing and able to take prescribed supplements
6. Child’s BMI between 18 and 30 kg/m2
7. There is no plan for the child to commence new treatments over the study period
8. Parent and child fluent in English
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or 12-month history in a child of any psychiatric disorder (including ADHD)
2. Child is currently taking pharmaceutical medications expected to affect behaviour and learning.
3. Current or history of clinically significant chronic medical condition in the child including but not limited to cardiovascular disease, organic brain disorder, seizure, or diabetes.
4. Any diagnosed learning disorder in the child
5. Child is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc).
6. Child is currently taking ashwagandha or other supplements that may affect cognition or sleep
7. Child has had a significant surgery over the last year

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)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 8 randomly permuted blocks, containing 10 participants per block.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous adult trials on ashwagandha, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 36 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 40 participants per group (80 participants in total). Forty participants will be recruited in Australia and 40 in India. Based on the 80 people recruited in Australia and India we have a suitable power to find an effect, even after dropouts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2021
Actual
7/09/2021
Date of last participant enrolment
Anticipated
29/04/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
80
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment outside Australia
Country [1] 23668 0
India
State/province [1] 23668 0

Funding & Sponsors
Funding source category [1] 308496 0
Commercial sector/Industry
Name [1] 308496 0
Shri Kartikeya Pharma
Country [1] 308496 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 309346 0
None
Name [1] 309346 0
Address [1] 309346 0
Country [1] 309346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308454 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 308454 0
Ethics committee country [1] 308454 0
Australia
Date submitted for ethics approval [1] 308454 0
01/10/2020
Approval date [1] 308454 0
03/03/2021
Ethics approval number [1] 308454 0
0063E-2020
Ethics committee name [2] 308455 0
Padmashree Dr D Y Patil Medical College, Hospital and Research Center Navi Mumbai
Ethics committee address [2] 308455 0
Ethics committee country [2] 308455 0
India
Date submitted for ethics approval [2] 308455 0
22/04/2021
Approval date [2] 308455 0
Ethics approval number [2] 308455 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110750 0
Dr Adrian Lopresti
Address 110750 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110750 0
Australia
Phone 110750 0
+61 894487376
Fax 110750 0
Email 110750 0
[email protected]
Contact person for public queries
Name 110751 0
Adrian Lopresti
Address 110751 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110751 0
Australia
Phone 110751 0
+61 894487376
Fax 110751 0
Email 110751 0
[email protected]
Contact person for scientific queries
Name 110752 0
Adrian Lopresti
Address 110752 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110752 0
Australia
Phone 110752 0
+61 894487376
Fax 110752 0
Email 110752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.