Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000800921
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
10/08/2020
Date last updated
28/03/2022
Date data sharing statement initially provided
10/08/2020
Date results provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an Oroxylum indicum extract (Sabroxy) on cognitive function in adults with mild cognitive impairment
Scientific title
Effects of an Oroxylum indicum extract (Sabroxy) on cognitive function in adults with mild cognitive impairment: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 301781 0
None
Universal Trial Number (UTN)
U1111-1255-3141
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 318248 0
Condition category
Condition code
Neurological 316260 316260 0 0
Other neurological disorders
Alternative and Complementary Medicine 316546 316546 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (1 capsule taken orally, twice daily after food at breakfast and dinner times for 12 weeks)

Condition 2: Oroxylum indicum extract (Sabroxy) (1 capsule taken orally, twice daily after food at breakfast and dinner times, delivering 1000mg a day, for 12 weeks)

Adherence to capsule intake will be monitored through capsule return and count.
Intervention code [1] 318077 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing either cellulose or rice powder) is matched to the Oroxylum indicum capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 324441 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 324441 0
Weeks 0 and 12
Secondary outcome [1] 384660 0
Change in cognitive performance as measured by the Montreal Cognitive Assessment (MoCA)
Timepoint [1] 384660 0
Weeks 0 and 12
Secondary outcome [2] 384661 0
Change in cognitive skills as measured by the Cognitive Failures Questionnaire (CFQ)
Timepoint [2] 384661 0
Weeks 0, 4, 8, and 12
Secondary outcome [3] 384662 0
Change in quality of life as measured by the CASP-19
Timepoint [3] 384662 0
Weeks 0, 4, 8, and 12
Secondary outcome [4] 384663 0
Change in blood concentration of brain-derived neurotrophic factor (BDNF)
Timepoint [4] 384663 0
Weeks 0 and 12

Eligibility
Key inclusion criteria
1. Adults (male and female) between 60 and 85
2. Residing in independent living accommodation
3. Subjective reports of memory or cognitive impairment as measured by answering ‘yes’ to any of the following questions: (1) Do you feel your memory and thinking is getting worse? or (2) Are you concerned about your decline in memory and thinking?
4. A score between the 10th and 40th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M)
5. Non-smoker
6. BMI between 18 and 35 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
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
2. Suffering from medical conditions including but not limited to: uncontrolled hypertension; myocardial infarction, unstable or severe cardiovascular disease including angina or congestive heart disease in the last year; bleeding disorders; type I diabetes; glaucoma; chronic renal failure; chronic hepatic disease; severe pulmonary disease; gastrointestinal disease requiring regular use of medications; gallbladder disease/gallstones/biliary disease; neurodegenerative or neurological disease
3. Diagnosis of significant psychiatric disorder, including schizophrenia, bipolar disorder, obsessive compulsive disorder, or personality disorder
4. A score greater than 10 on the Geriatric Depression Scale, short form (GDS-SF)
5. History of stroke, seizures, or head injury (with loss of consciousness).
6. Significant hearing loss that may impact ability to complete phone assessment
7. Regular medication intake including anti-coagulant drugs, anti-cholinergics, acetylcholinesterase inhibitors, steroid medications.
8. Change in medication in the last 3 months or expectation to change during the study duration
9. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
10. Current or 12-month history of illicit drug abuse
11. Alcohol intake greater than 14 standard drinks per week
12. 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 not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly and equally assigned to two groups (Oroxylum indicum extract and placebo). These groups are named group 1 and group 2, respectively. The research investigators and participants will be unaware of which treatment these groups represent. Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 10 randomly permuted blocks, containing 8 participants per block. Participant identification number (1 to 80) will be allocated according to the order of participant enrolment in the study.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies on herbal treatments for mild cognitive impairment, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 72 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), which should give us 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. Montreal Cognitive Assessment (MoCA)
3. Cognitive Failures Questionnaire (CFQ)
4. CASP-19
5. Brain-derived neurotrophic factor (BDNF)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2020
Actual
15/09/2020
Date of last participant enrolment
Anticipated
29/01/2021
Actual
6/11/2020
Date of last data collection
Anticipated
30/04/2021
Actual
5/02/2021
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306212 0
Commercial sector/Industry
Name [1] 306212 0
Sabinsa Corporation
Country [1] 306212 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 306689 0
None
Name [1] 306689 0
Address [1] 306689 0
Country [1] 306689 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306424 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 306424 0
Ethics committee country [1] 306424 0
Australia
Date submitted for ethics approval [1] 306424 0
02/06/2020
Approval date [1] 306424 0
16/07/2020
Ethics approval number [1] 306424 0
0070E_2020

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

Contacts
Principal investigator
Name 103826 0
Dr Adrian Lopresti
Address 103826 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 103826 0
Australia
Phone 103826 0
+61894487376
Fax 103826 0
Email 103826 0
[email protected]
Contact person for public queries
Name 103827 0
Adrian Lopresti
Address 103827 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 103827 0
Australia
Phone 103827 0
+61894487376
Fax 103827 0
Email 103827 0
[email protected]
Contact person for scientific queries
Name 103828 0
Adrian Lopresti
Address 103828 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 103828 0
Australia
Phone 103828 0
+61894487376
Fax 103828 0
Email 103828 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.