Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000655842
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 cognition, energy, and mood in adults with self-reported, cognitive and energy problems
Scientific title
Effects of an Ashwagandha extract (KSM-66®) on cognition, energy, and mood in adults with self-reported, cognitive and energy problems: a randomised, double-blind, placebo-controlled multi-national study
Secondary ID [1] 304115 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance 321796 0
Energy 321797 0
Mood 321798 0
Condition category
Condition code
Neurological 319522 319522 0 0
Other neurological disorders
Alternative and Complementary Medicine 319523 319523 0 0
Herbal remedies
Mental Health 319524 319524 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ashwagandha extract (KSM-66) (1 capsule taken orally, twice daily with breakfast and dinner, delivering 600 mg a day for 8 weeks)

Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
Intervention code [1] 320450 0
Treatment: Other
Comparator / control treatment
Placebo (containing maltodextrin) is matched to the ashwagandha extract capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 327392 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 327392 0
Day 0 and week 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 394910 0
Change in the Mental Fatigue Questionnaire
Timepoint [1] 394910 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [2] 394911 0
Change in the Profile of Moods States, abbreviated version
Timepoint [2] 394911 0
Day 0, weeks 4, & 8 post-intervention commencement
Secondary outcome [3] 394912 0
Change in the Behavior Rating Inventory of Executive Function – Adult Version
Timepoint [3] 394912 0
Day 0 and weeks 8 post-intervention commencement

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 30 and 75 years
2. Residing in independent living accommodation
3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration?
4. Subjective reports of fatigue/energy problems by answering ‘yes’ to the following question: Do you have problems with fatigue or energy?
5. Non-smoker
6. BMI between 18 and 30 kg/m2
7. No plan to commence new treatments over the study period
8. Understand, willing and able to comply with all study procedures
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
3. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy
4. History of stroke or seizures or head injury (with loss of consciousness).
5. Regular medication intake including anti-coagulant drugs, anti-cholinergics, acetylcholinesterase inhibitors, or steroid medications.
6. Change in medication in the last 3 months or expectation to change during the study duration
7. Current nutrient deficiencies including low iron or vitamin B12 concentrations
8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
9. Current or 12-month history of illicit drug abuse
10. Alcohol intake greater than 14 standard drinks per week
11. Any significant surgeries 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 a previous study 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.

Pre and post analyses will be conducted to determine changes in the following:

1. Computerised Mental Performance Assessment System (COMPASS)
2. Profile of Mood States, abbreviated version (POMS-A)
3. Mental Fatigue Scale (MFS)
4. Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2021
Actual
16/09/2021
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
80
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment outside Australia
Country [1] 23667 0
India
State/province [1] 23667 0

Funding & Sponsors
Funding source category [1] 308495 0
Commercial sector/Industry
Name [1] 308495 0
Shri Kartikeya Pharma
Country [1] 308495 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] 309345 0
None
Name [1] 309345 0
Address [1] 309345 0
Country [1] 309345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308452 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 308452 0
Ethics committee country [1] 308452 0
Australia
Date submitted for ethics approval [1] 308452 0
01/10/2020
Approval date [1] 308452 0
14/06/2021
Ethics approval number [1] 308452 0
0078E_2020
Ethics committee name [2] 308453 0
Padmashree Dr D Y Patil Medical College, Hospital and Research Center Navi Mumbai
Ethics committee address [2] 308453 0
Ethics committee country [2] 308453 0
India
Date submitted for ethics approval [2] 308453 0
22/04/2021
Approval date [2] 308453 0
Ethics approval number [2] 308453 0

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

Contacts
Principal investigator
Name 110746 0
Dr Adrian Lopresti
Address 110746 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110746 0
Australia
Phone 110746 0
+61 894487376
Fax 110746 0
Email 110746 0
[email protected]
Contact person for public queries
Name 110747 0
Adrian Lopresti
Address 110747 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110747 0
Australia
Phone 110747 0
+61 894487376
Fax 110747 0
Email 110747 0
[email protected]
Contact person for scientific queries
Name 110748 0
Adrian Lopresti
Address 110748 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110748 0
Australia
Phone 110748 0
+61 894487376
Fax 110748 0
Email 110748 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.