Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000609853
Ethics application status
Approved
Date submitted
24/04/2021
Date registered
21/05/2021
Date last updated
22/11/2022
Date data sharing statement initially provided
21/05/2021
Date results provided
22/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an Ocimum tenuiflorum (Holy Basil) extract on perceived stress, mood, sleep, and the stress response in healthy adults experiencing high stress
Scientific title
The effects of an Ocimum tenuiflorum (Holy Basil) extract on perceived stress, mood, sleep, and the stress response in healthy adults experiencing high stress: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 304054 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High stress 321698 0
Unsatisfactory sleep 321699 0
Condition category
Condition code
Mental Health 319436 319436 0 0
Anxiety
Alternative and Complementary Medicine 319437 319437 0 0
Herbal remedies
Mental Health 319438 319438 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (2 capsules taken orally, twice daily with breakfast and dinner for 8 weeks)

Condition 2: Ocimum tenuiflorum (Holy Basil) extract (2 capsules taken orally, twice daily with breakfast and dinner, delivering 250 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] 320375 0
Treatment: Other
Comparator / control treatment
Placebo (containing maltodextrin) is matched to the Ocimum tenuiflorum extract capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 327306 0
Change in stress levels as measured by the Perceived Stress Scale
Timepoint [1] 327306 0
Day 0, weeks 2, 4, 6, and 8 (primary endpoint) post-intervention commencement
Secondary outcome [1] 394523 0
Change in the Profile of Mood States, Abbreviated Version
Timepoint [1] 394523 0
Day 0, weeks 2, 4, 6, and 8 post-intervention commencement
Secondary outcome [2] 394524 0
Change in the Athens Insomnia Scale
Timepoint [2] 394524 0
Day 0, weeks 2, 4, 6, and 8 post-intervention commencement
Secondary outcome [3] 394525 0
Change in the Restorative Sleep Questionnaire
Timepoint [3] 394525 0
Day 0, weeks 2, 4, 6, and 8 post-intervention commencement
Secondary outcome [4] 394526 0
Change in the Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
Timepoint [4] 394526 0
Day 0, weeks 4 and 8 post-intervention commencement
Secondary outcome [5] 394527 0
Change in total sleep time as measured by the Fitbit wrist-worn tracker
Timepoint [5] 394527 0
Weekly average of weeks 1, 2, 3, 4, 5, 6. 7, and 8 post-intervention commencement
Secondary outcome [6] 394528 0
Change in sleep latency as measured by the Fitbit wrist-worn tracker
Timepoint [6] 394528 0
Weekly average of weeks 1, 2, 3, 4, 5, 6. 7, and 8 post-intervention commencement
Secondary outcome [7] 394529 0
Change in sleep efficiency as measured by the Fitbit wrist-worn tracker
Timepoint [7] 394529 0
Weekly average of weeks 1, 2, 3, 4, 5, 6. 7, and 8 post-intervention commencement
Secondary outcome [8] 394530 0
Change in resting heart rate as measured by the Fitbit wrist-worn tracker
Timepoint [8] 394530 0
Weekly average of weeks 1, 2, 3, 4, 5, 6. 7, and 8 post-intervention commencement
Secondary outcome [9] 394531 0
Group differences in hair cortisol concentrations
Timepoint [9] 394531 0
Day 0 and weeks 8 post-intervention commencement
Secondary outcome [10] 394532 0
Group differences in salivary cortisol during and after exposure to the Maastricht Acute Stress Test
Timepoint [10] 394532 0
Week 8 post-intervention commencement
Secondary outcome [11] 394533 0
Group differences in salivary a-amylase during and after exposure to the Maastricht Acute Stress Test
Timepoint [11] 394533 0
Week 8 post-intervention commencement
Secondary outcome [12] 394534 0
Group differences in self-reported stress levels during and after exposure to the Maastricht Acute Stress Test
Timepoint [12] 394534 0
Week 8 post-intervention commencement
Secondary outcome [13] 394535 0
Group differences in blood pressure (measured using a digital blood pressure cuff), during and after exposure to the Maastricht Acute Stress Test
Timepoint [13] 394535 0
Week 8 post-intervention commencement
Secondary outcome [14] 394536 0
Group differences in pulse rate during and after exposure to the Maastricht Acute Stress Test. The pulse rate will be measured using a digital blood pressure cuff.
Timepoint [14] 394536 0
Week 8 post-intervention commencement

Eligibility
Key inclusion criteria
1. Adults aged 18-65 years of age
2. Body mass index between 18.5 kg/m2 and 30 kg/m2
3. Currently experiencing high stress (as determined by a Perceived Stress Scale score of 14 or higher)
4. Stressor or anxiety has been present for greater than a month
5. Self-reported sleep difficulties (as determined by a rating of 3 or higher on at least one of the first 5 questions of the Insomnia Symptom Questionnaire)
6. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pill are permissible.
7. Non-smoker
8. No plan to commence new treatments over the study period
9. Willing to wear a Fitbit to bed for the duration of the study
10. Willing to provide a personally-signed informed consent form detailing all pertinent aspects of the trial.
11. Willing and able to take prescribed capsules for 8 weeks
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Anticipated major stressor, change or medical procedure occurring during the study period likely to affect psychological or physical status
2. Participation in another clinical trial within 30 days before screening
3. Suffer from mental-health disorder other than mild depressive or anxiety symptoms as measured by Patient Health Questionnaire-4
4. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/ gallstones/ biliary disease, autoimmune disease, endocrine disease, and acute or chronic pain condition
5. Alcohol consumption greater than 14 standard drinks per week
6. Current or 12-month history of illicit drug abuse
7. Caffeine intake greater than 4 cups a day
8. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant.
9. Currently taking supplements that may impact on treatment outcome

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)
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
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 studies on herbal extracts, 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 50 participants per group (100 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2021
Actual
2/06/2021
Date of last participant enrolment
Anticipated
20/08/2021
Actual
8/10/2021
Date of last data collection
Anticipated
12/11/2021
Actual
14/12/2021
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308438 0
Commercial sector/Industry
Name [1] 308438 0
Natural Remedies Pvt. Ltd.
Country [1] 308438 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] 309271 0
None
Name [1] 309271 0
Address [1] 309271 0
Country [1] 309271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308395 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 308395 0
Ethics committee country [1] 308395 0
Australia
Date submitted for ethics approval [1] 308395 0
01/04/2021
Approval date [1] 308395 0
02/06/2021
Ethics approval number [1] 308395 0
0086E_2021

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

Contacts
Principal investigator
Name 110570 0
Dr Adrian Lopresti
Address 110570 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110570 0
Australia
Phone 110570 0
+61 08 94487376
Fax 110570 0
Email 110570 0
[email protected]
Contact person for public queries
Name 110571 0
Adrian Lopresti
Address 110571 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110571 0
Australia
Phone 110571 0
+61 08 94487376
Fax 110571 0
Email 110571 0
[email protected]
Contact person for scientific queries
Name 110572 0
Adrian Lopresti
Address 110572 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 110572 0
Australia
Phone 110572 0
+61 08 94487376
Fax 110572 0
Email 110572 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.