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Trial registered on ANZCTR
Registration number
ACTRN12625000129482
Ethics application status
Approved
Date submitted
29/01/2025
Date registered
5/02/2025
Date last updated
30/03/2025
Date data sharing statement initially provided
5/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
An examination into the anti-stress and anti-fatigue effects of an ashwagandha extract (NRAHG001) in stressed adults
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Scientific title
An examination into the anti-stress and anti-fatigue effects of an ashwagandha extract (NRAHG001) in stressed adults: a randomised, double-blind, placebo-controlled trial
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Secondary ID [1]
313837
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None
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Universal Trial Number (UTN)
U1111-1318-3171
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fatigue
336485
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Stress
336484
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Condition category
Condition code
Mental Health
332996
332996
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0
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Other mental health disorders
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Mental Health
332995
332995
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0
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Anxiety
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Alternative and Complementary Medicine
332997
332997
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0
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Herbal remedies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Ashwagandha extract (NRAHG001) (1 capsule taken orally, once daily in the morning with or without food, delivering 30mg for 4 weeks). Adherence to capsule intake will be measured by capsule return at day 7 and 28.
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Intervention code [1]
330421
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Treatment: Other
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Comparator / control treatment
A matching placebo (cellulose) in terms of taste and appearance and containing all ingredients except the active ingredient (ashwagandha)
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Control group
Placebo
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Outcomes
Primary outcome [1]
340537
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Stress
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Assessment method [1]
340537
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Depression, Anxiety, and Stress Scale (DASS-21), stress score
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Timepoint [1]
340537
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Days 0 (day before commencement of intervention), 7, 14, 21 and 28 (primary endpoint) post-intervention commencement
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Secondary outcome [1]
444375
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Stress
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Assessment method [1]
444375
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Single-item mood rating assessing stress
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Timepoint [1]
444375
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Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
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Secondary outcome [2]
444385
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Salivary chromogranin A
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Assessment method [2]
444385
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Salivary collection immediately before exposure to the socially evaluated cold-pressor test and 30 minutes after exposure to the socially evaluated cold-pressor test
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Timepoint [2]
444385
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [3]
444383
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Skin conductance before and after exposure to the socially evaluated cold-pressor test
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Assessment method [3]
444383
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A watch that measures skin conductance
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Timepoint [3]
444383
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [4]
444374
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Fatigue
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Assessment method [4]
444374
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Chalder Fatigue Scale
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Timepoint [4]
444374
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Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
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Secondary outcome [5]
444379
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Mental fatigue
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Assessment method [5]
444379
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Visual analague mental fatigue ratings before and after exposure to the socially evaluated cold-pressor test
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Timepoint [5]
444379
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [6]
444373
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Depression
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Assessment method [6]
444373
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Depression, Anxiety, and Stress Scale (DASS-21), depression score
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Timepoint [6]
444373
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Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
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Secondary outcome [7]
444386
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Urinary metabolites involved in normal cellular metabolism
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Assessment method [7]
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Random urine collection
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Timepoint [7]
444386
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Days 0 (day before commencement of intervention) and 28 post-intervention commencement
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Secondary outcome [8]
444382
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Skin temperature before and after exposure to the socially evaluated cold-pressor test
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Assessment method [8]
444382
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A watch that measures skin temperature
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Timepoint [8]
444382
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [9]
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Blood pressure before and after exposure to the socially evaluated cold-pressor test
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Assessment method [9]
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Blood pressure using and automatic blood pressure monitor
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Timepoint [9]
444380
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [10]
444376
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Anxiety
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Assessment method [10]
444376
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Single-item mood rating assessing anxiety
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Timepoint [10]
444376
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Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
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Secondary outcome [11]
444384
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Salivary cortisol
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Assessment method [11]
444384
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Salivary collection immediately before exposure to the socially evaluated cold-pressor test and 30 minutes after exposure to the socially evaluated cold-pressor test
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Timepoint [11]
444384
0
Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [12]
444372
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Anxiety
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Assessment method [12]
444372
0
Depression, Anxiety, and Stress Scale (DASS-21), anxiety score
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Timepoint [12]
444372
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Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
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Secondary outcome [13]
444377
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Depression
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Assessment method [13]
444377
0
Single-item mood rating assessing depression
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Timepoint [13]
444377
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Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
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Secondary outcome [14]
444378
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Stress
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Assessment method [14]
444378
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Visual analague stress ratings before and after exposure to the socially evaluated cold-pressor test
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Timepoint [14]
444378
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Day 7 and day 28 (post-intervention commencement)
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Secondary outcome [15]
444381
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Pulse rate before and after exposure to the socially evaluated cold-pressor test
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Assessment method [15]
444381
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A watch that measures pulse rate
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Timepoint [15]
444381
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Day 7 and day 28 (post-intervention commencement)
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Eligibility
Key inclusion criteria
1. Adults (male and female) aged between 18 and 65 years
2. Experiencing high self-reported perceived stress as indicated by a score between 8 and 16 on the DASS-21 stress subscale
3. Non-smoker
4. Body mass index (BMI) between 18 and 35 kg/m2
5. No plan to commence new treatments over the study period.
6. Understand, willing and able to comply with all study procedures.
7. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/ malignancy.
2. Diagnosis of medical or psychiatric conditions including but not limited to a psychiatric disorder (other than mild-to-moderate depression or anxiety) and/or neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
3. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
4. Change in medication in the last 3 months or an expectation to change during the study duration.
5. Current use of supplements that contain ashwagandha or other supplements that may affect treatment outcomes.
6. In the last month, commenced or changed the dose of nutritional and/or herbal supplements that may impact treatment outcomes.
7. Planned major lifestyle change in the next 2 months.
8. Alcohol intake greater than 14 standard drinks per week
9. Current (or in the last 12 months) have regularly used illicit drugs
10. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
11. Any significant surgeries over the last year
12. Participation in any other clinical trial in the month
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/02/2025
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Actual
14/03/2025
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Date of last participant enrolment
Anticipated
29/08/2025
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
60
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Accrual to date
11
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
318308
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Commercial sector/Industry
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Name [1]
318308
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Natural Remedies Pvt Ltd
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Address [1]
318308
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Country [1]
318308
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India
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
320693
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Commercial sector/Industry
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Name [1]
320693
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Natural Remedies Pvt Ltd
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Address [1]
320693
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Country [1]
320693
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India
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316943
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
316943
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https://niim.com.au/research/niim-human-research-ethics-committee
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Ethics committee country [1]
316943
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Australia
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Date submitted for ethics approval [1]
316943
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13/01/2025
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Approval date [1]
316943
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11/03/2025
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Ethics approval number [1]
316943
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0153E_2025
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Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 60 generally healthy adults aged 18 to 65 experiencing high stress will be randomly assigned to receive an ashwagandha extract (NRAHG001) or a placebo for 28 days. Changes in self-reported stress, mood and fatigue will be measured over time. Moreover, changes in the stress response using subjective and physiological measures after exposure to an experimental stress procedure (Socially Evaluated Cold-Pressor Test) will be investigated. The effects of ashwagandha supplementation on metabolomic markers will also be investigated to help understand the mechanism of action associated with ashwagandha supplementation. It is hypothesised that ashwagandha will be associated with a reduction in self-reported stress, and improvments in overall mood and fatigue.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139510
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Dr Adrian Lopresti
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Address
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
139510
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Australia
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Phone
139510
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+61 08 94487376
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Fax
139510
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Email
139510
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[email protected]
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Contact person for public queries
Name
139511
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Adrian Lopresti
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Address
139511
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
139511
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Australia
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Phone
139511
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+61 08 94487376
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Fax
139511
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Email
139511
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[email protected]
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Contact person for scientific queries
Name
139512
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Adrian Lopresti
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Address
139512
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
139512
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Australia
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Phone
139512
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+61 08 94487376
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Fax
139512
0
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Email
139512
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Case-by-case basis at the discretion of the study sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Individual participant data underlying published results
What types of analyses could be done with individual participant data?
•
for IPD meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approvals by Principal Investigator (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
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.
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