Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000770965
Ethics application status
Approved
Date submitted
12/06/2020
Date registered
27/07/2020
Date last updated
28/03/2022
Date data sharing statement initially provided
27/07/2020
Date results provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a Bacopa Monnieri extract (Bacognize) on sleep quality and stress parameters in healthy adults with poor sleep.
Scientific title
Effects of a Bacopa Monnieri extract (Bacognize) on sleep quality and stress parameters in healthy adults with poor sleep: a randomised, double-blind, placebo-controlled study.
Secondary ID [1] 301473 0
None
Universal Trial Number (UTN)
U1111-1253-4808
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unsatisfactory sleep 317795 0
Stress 317796 0
Condition category
Condition code
Neurological 315857 315857 0 0
Other neurological disorders
Metabolic and Endocrine 315858 315858 0 0
Normal metabolism and endocrine development and function
Alternative and Complementary Medicine 315903 315903 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (1 capsule twice daily for 4 weeks)

Condition 2: Bacopa monnieri extract (Bacognize) (1 capsule twice daily, delivering 300mg a day, for 4 weeks)

Adherence to tablet intake will be monitored through tablet return and count.
Intervention code [1] 317785 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing either cellulose or rice powder) is matched to the Bacopa monnieri capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 324068 0
Change in sleep quality as assessed by the Bergen Insomnia Index (BIS).
Timepoint [1] 324068 0
Days -2, 7, 14, 21, and 27
Primary outcome [2] 324327 0
Change in sleep patterns as assessed by the Pittsburgh Sleep Diary
Timepoint [2] 324327 0
Days -2, -1, 3, 7, 14, 21, 26, and 27
Secondary outcome [1] 383667 0
Change in quality of life associated with excess sleepiness as assessed by the Functional Outcomes of Sleep Questionnaire (FOSQ-10).
Timepoint [1] 383667 0
Days -2, 7, 14, 21, and 26
Secondary outcome [2] 383668 0
Change in quality of life as assessed by the Short Form-36
Timepoint [2] 383668 0
Days -1 and 27
Secondary outcome [3] 383669 0
Change in morning salivary cortisol concentrations
Timepoint [3] 383669 0
Days -2 and 26
Secondary outcome [4] 383671 0
Change in evening salivary cortisol concentrations
Timepoint [4] 383671 0
Days -2 and 26
Secondary outcome [5] 383788 0
Change in evening salivary melatonin concentrations
Timepoint [5] 383788 0
Days -2 and 26
Secondary outcome [6] 383789 0
Change in morning salivary Dehydroepiandrosterone sulphate (DHEAs) concentrations
Timepoint [6] 383789 0
Day -2 and 26
Secondary outcome [7] 383790 0
Change in morning salivary immunoglobulin A (sIgA) concentrations
Timepoint [7] 383790 0
Day -2 and 26
Secondary outcome [8] 383791 0
Change in morning salivary alpha-amylase (sAA) concentrations
Timepoint [8] 383791 0
Day -2 and 26
Secondary outcome [9] 383792 0
Change in morning salivary C-reactive protein (CRP) concentrations
Timepoint [9] 383792 0
Day -2 and 26
Secondary outcome [10] 383793 0
Change in salivary fatigue index
Timepoint [10] 383793 0
Day -1 and 27

Eligibility
Key inclusion criteria
1. Adults (male and female) between 18 and 70
2. Self-reported symptoms of poor sleep lasting greater than 4 weeks (participants will need to give a score of 3 or more on at least one of the first four questions on the BIS and a score of 3 or more on at least one of the last two questions)
3. Medication-free for at least 4 weeks apart from the contraceptive pill and no more than once a week use of pain-relieving medications.
4. Non-smoker
5. BMI between 20 and 30
6. Typical bedtime between 9 p.m. and 12 a.m.
7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Employed in night shift work or rotational shift work
2. Suffer from sleep disorder other than moderate insomnia (e.g, sleep apnoea, restless leg syndrome, periodic limb movement disorder)
3. Chronic sleep disturbance greater than 1 year
4. Suffer from mental health disorder (other than mild depressive or anxiety symptoms as measured by the Depression, Anxiety and Stress Scale-21)
5. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
6. Alcohol consumption > 14 standard drinks per week
7. Experiencing external factors that may affect sleep patterns (e.g., infant/children regularly awakening, excess noise, snoring partner, pain condition)
8. Currently receiving non-pharmacological treatment of sleep disorders (e.g., cognitive behavioural therapy, relaxation therapy)
9. Current or 12-month history of illicit drug abuse
10. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
11. Suffering from medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), acute or chronic pain affecting sleep
12. Current use of supplements that may affect sleep
13. Currently taking Bacopa supplements

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 be randomly and equally assigned to two groups (Bacopa monnieri 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. This computer-generated randomisation structure will comprise 10 randomly permuted blocks, containing 10 participants per block. Participant identification number (1 to 100) will be allocated according to the order of participant enrolment in the study.

Allocation is not concealed
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 10 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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies on herbal treatments for insomnia, 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 50 participants per group (100 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. Bergen Insomnia Scale (BIS)
2. Pittsburgh Sleep diary (total sleep time, time taken to fall asleep, sleep efficiency, sleep quality rating)
3. Functional Outcomes of Sleep Questionnaire (FOSQ-10)
4. Quality of Life Questionnaire (SF-36)
5. Salivary evening cortisol and melatonin concentrations
6. Salivary morning cortisol, DHEAs, immunoglobulin A (sIgA), alpha-amylase, and C-reactive protein (CRP)
7. Salivary fatigue index (Morning, Midday, and Evening)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/07/2020
Actual
31/07/2020
Date of last participant enrolment
Anticipated
1/09/2020
Actual
30/09/2020
Date of last data collection
Anticipated
1/10/2020
Actual
30/10/2020
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 305911 0
Commercial sector/Industry
Name [1] 305911 0
Verdure Sciences Inc
Country [1] 305911 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] 306364 0
None
Name [1] 306364 0
Address [1] 306364 0
Country [1] 306364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306162 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 306162 0
Ethics committee country [1] 306162 0
Australia
Date submitted for ethics approval [1] 306162 0
17/04/2020
Approval date [1] 306162 0
26/05/2020
Ethics approval number [1] 306162 0
0066E_2020

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

Contacts
Principal investigator
Name 102926 0
Dr Adrian Lopresti
Address 102926 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 102926 0
Australia
Phone 102926 0
+61894487376
Fax 102926 0
+61894478217
Email 102926 0
[email protected]
Contact person for public queries
Name 102927 0
Adrian Lopresti
Address 102927 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 102927 0
Australia
Phone 102927 0
+61894487376
Fax 102927 0
+61894478217
Email 102927 0
[email protected]
Contact person for scientific queries
Name 102928 0
Adrian Lopresti
Address 102928 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 102928 0
Australia
Phone 102928 0
+61894487376
Fax 102928 0
+61894478217
Email 102928 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.