Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001226796
Ethics application status
Approved
Date submitted
5/09/2022
Date registered
12/09/2022
Date last updated
20/10/2022
Date data sharing statement initially provided
12/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Herbal and Nutritional Medicines for Managing Post-Flood Stress and Anxiety: A Randomised Controlled Trial
Scientific title
Feasibility of Herbal and Nutritional Medicines for Managing Post-Flood Stress and Anxiety: A Randomised Controlled Trial
Secondary ID [1] 307865 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The ARK Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 327482 0
Anxiety 327483 0
Condition category
Condition code
Mental Health 324606 324606 0 0
Anxiety
Mental Health 324661 324661 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three different interventions, herbal and nutritional supplements. Each participant will only receive one of the interventions. Adherence and compliance are measured via diary, and at Week 6 with a final tablet count at the telehealth visit.

Arm 1: Noble Kava (Fijikava), listed medicine
Per capsule: Piper methysticum (Kava) ext. dry conc – 695 mg from minimum fresh root – 6.95 g, standardised to contain Kavalactones (per capsule) –50 mg.
Dose: 200mg daily, oral (2 capsules twice daily)
Duration: 6 weeks

Arm 2: Executive B Stress Formula (Blackmores), Listed Medicine
Per tablet:
- Thiamine hydrochloride (thiamine vitamin B1 66.9mg) 75 mg
- Riboflavin (vitamin B2) 10 mg
- Nicotinamide 100 mg
- Calcium panthothenate (pantothenic acid 68.8 mg) 75 mg
- Pyridoxine hydrochloride (pyrdioxine 20.6 mg) 25 mg
- Cyanocobalamin (vitamin B12) 30 micrograms
- Biotin (vitamin H) 20 micrograms
- Calcium ascorbate dehydrate 145.5 mg
- Ascorbic acid 130 mg (total vitamin C 250 mg)
- D-alpha tocopheryl acid succinate (vitamin E 50 U) 41.3 mg
- Magnesium phosphate pentahydrate (magnesium 28.9 mg) 140 mg
- Calcium phosphate (calcium 37 mg) 95.6 mg
- Monobasic potassium phosphate (potassium33.7 mg) 117 mg
- Folic acid 150 micrograms
- Avena sativa (oats) extract dry conc. 25 mg (equiv. to dry seed 250 mg)
- Passiflora incarnata (passion flower) extract dry conc. 20 mg (equiv. to dry herb 100 mg)
- Choline bitartate 25 g
Dose: 2 tablets daily, oral (1 tablet twice daily)
Duration: 6 weeks

Arm 3: Ashwagandha Complex Day, listed medicine
Per capsule: Bacopa monnieri whole plant Extract dry concentrate 150 mg equivalent: Bacopa monnieri (Dry) 3000 mg, Withania somnifera root Extract dry concentrate 150 mg equivalent: Withania somnifera (Dry) 1.5 g
Dose: 4 tablets daily, oral (2 tablets twice daily)
Duration: 6 weeks
Intervention code [1] 324332 0
Treatment: Other
Intervention code [2] 324370 0
Treatment: Drugs
Comparator / control treatment
Waiting list control group
Participants in this group will not receive an intervention during the intervention period. At the end of the trial, they can chose one of the above listed products for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 332463 0
Feasibility of study procedures: recruitment, attrition rate, survey completion rate.
This will be measured via audit of study records.
Timepoint [1] 332463 0
6 weeks after starting intervention
Primary outcome [2] 332474 0
Feasibility of study interventions is a composite measure, including compliance, satisfaction, safety, and experiences with the interventions.
- Compliance will be measured via tablet count, and a a diary of medication use.
- Satisfaction will be assessed via a 5-point Likert scale.
- Safety will be assessed via liver and kidney function (blood pathology), and via adverse events assessed at every visit time point/via survey.
Timepoint [2] 332474 0
6 weeks after starting intervention
Secondary outcome [1] 413634 0
Perceived Stress Scale (PSS)
Timepoint [1] 413634 0
Week 2, 4, and 6 after starting intervention
Secondary outcome [2] 413635 0
Psychological distress due to traumatic events (Impact of Event Scale - IES)
Timepoint [2] 413635 0
Week 6 after starting intervention
Secondary outcome [3] 413636 0
Psychological distress (Kessler Psychological Distress Scale - K-10)
Timepoint [3] 413636 0
Week 6 after starting intervention
Secondary outcome [4] 413637 0
Quality of Life (Short Form - SF-12)
Timepoint [4] 413637 0
Week 6 after starting intervention
Secondary outcome [5] 413638 0
Sleep Disturbance (PROMIS Sleep Disturbance)
Timepoint [5] 413638 0
Week 6 after starting intervention
Secondary outcome [6] 413639 0
Cheerfulness (State-Trait Cheerfulness Inventory - STCI)
Timepoint [6] 413639 0
Week 6 after starting intervention

Eligibility
Key inclusion criteria
Adults aged 18 years or older
Resident in the flood affected area in the Norther Rivers and Regional New South Wales
Have self-reported significant increase in post flood stress and/or anxiety within 12 months
Mild to moderate perceived stress (PSS 14-26 pts)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy or breastfeeding
- Severe mental health, including major depression with or without suicidal ideation (PTSD accepted if stable ongoing psychological care)
- Neurological disorders
- Serious medical conditions, acute or chronic
- Liver disease (diagnosed, or elevated liver enzymes (greater than 1.2xULN)
- Alcohol use disorder (high-risk consumption)
- Concurrent use of any medication judged to have a clinically significant potential for interactions with the herbal medicines
- Current use of trial products
- Use of psychotropic medication
- Use of psychoactive herbal medicines (a 1-week washout is acceptable)
- Current oral steroid administration
- Current chemotherapy, radiation, immune suppressant therapy, or immunotherapy
- Current warfarin administration
- Limited ability to read, speak, write, or understand English to ensure participant understanding of all aspects of the study

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)
The group allocation will be provided via the computer system (REDCap) once the participant has been enrolled, and all participant data have been entered, and the researcher has indicated that written informed consent has been provided. REDCap will provide the group allocation upon randomisation.
The trial researchers randomising the participants will not have access to the randomisation list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be a computer-generated random number based on block randomisation with varying block length ranging from 4 to 8. One stratum will be applied, i.e., participants’ gender. The randomisation sequence will be generated via the online platform randomizer.org.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome is feasibility, and it will be reported descriptively as absolute and relative frequencies, means and standard deviations or median and ranges depending on the data distribution.
Secondary continuous outcomes will be analysed using Linear Mix Methods Model for between subject across time effects between groups, in addition to a between groups analysis using univariate analysis (ANCOVA), which models the posttreatment outcome as a function of treatment group (classified factor), and the respective baseline value (linear covariate). Efficacy estimates will be reported as group differences with 95% confidence intervals, and effect sizes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 312140 0
University
Name [1] 312140 0
National Centre for Naturopathic Medicine
Country [1] 312140 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Military Rd
East Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 313707 0
None
Name [1] 313707 0
Address [1] 313707 0
Country [1] 313707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311534 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 311534 0
Ethics committee country [1] 311534 0
Australia
Date submitted for ethics approval [1] 311534 0
18/07/2022
Approval date [1] 311534 0
02/09/2022
Ethics approval number [1] 311534 0
2022/123

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

Contacts
Principal investigator
Name 121442 0
A/Prof Romy Lauche
Address 121442 0
Southern Cross University
Military Rd
East Lismore NSW 2480
Country 121442 0
Australia
Phone 121442 0
+61 266203362
Fax 121442 0
Email 121442 0
[email protected]
Contact person for public queries
Name 121443 0
Romy Lauche
Address 121443 0
Southern Cross University
Military Rd
East Lismore NSW 2480
Country 121443 0
Australia
Phone 121443 0
+61 266203362
Fax 121443 0
Email 121443 0
[email protected]
Contact person for scientific queries
Name 121444 0
Romy Lauche
Address 121444 0
Southern Cross University
Military Rd
East Lismore NSW 2480
Country 121444 0
Australia
Phone 121444 0
+61 266203362
Fax 121444 0
Email 121444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by HREC


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.