Trial Review

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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
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
Secondary ID [1] 313837 0
None
Universal Trial Number (UTN)
U1111-1318-3171
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fatigue 336485 0
Stress 336484 0
Condition category
Condition code
Mental Health 332996 332996 0 0
Other mental health disorders
Mental Health 332995 332995 0 0
Anxiety
Alternative and Complementary Medicine 332997 332997 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330421 0
Treatment: Other
Comparator / control treatment
A matching placebo (cellulose) in terms of taste and appearance and containing all ingredients except the active ingredient (ashwagandha)
Control group
Placebo

Outcomes
Primary outcome [1] 340537 0
Stress
Timepoint [1] 340537 0
Days 0 (day before commencement of intervention), 7, 14, 21 and 28 (primary endpoint) post-intervention commencement
Secondary outcome [1] 444375 0
Stress
Timepoint [1] 444375 0
Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
Secondary outcome [2] 444385 0
Salivary chromogranin A
Timepoint [2] 444385 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [3] 444383 0
Skin conductance before and after exposure to the socially evaluated cold-pressor test
Timepoint [3] 444383 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [4] 444374 0
Fatigue
Timepoint [4] 444374 0
Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
Secondary outcome [5] 444379 0
Mental fatigue
Timepoint [5] 444379 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [6] 444373 0
Depression
Timepoint [6] 444373 0
Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
Secondary outcome [7] 444386 0
Urinary metabolites involved in normal cellular metabolism
Timepoint [7] 444386 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [8] 444382 0
Skin temperature before and after exposure to the socially evaluated cold-pressor test
Timepoint [8] 444382 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [9] 444380 0
Blood pressure before and after exposure to the socially evaluated cold-pressor test
Timepoint [9] 444380 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [10] 444376 0
Anxiety
Timepoint [10] 444376 0
Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
Secondary outcome [11] 444384 0
Salivary cortisol
Timepoint [11] 444384 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [12] 444372 0
Anxiety
Timepoint [12] 444372 0
Days 0 (day before commencement of intervention), 7, 14, 21 and 28 post-intervention commencement
Secondary outcome [13] 444377 0
Depression
Timepoint [13] 444377 0
Day 0 (pre-commencement of intervention) and every day for 4 weeks (post-intervention commencement)
Secondary outcome [14] 444378 0
Stress
Timepoint [14] 444378 0
Day 7 and day 28 (post-intervention commencement)
Secondary outcome [15] 444381 0
Pulse rate before and after exposure to the socially evaluated cold-pressor test
Timepoint [15] 444381 0
Day 7 and day 28 (post-intervention commencement)

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Opaque numbered containers
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)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/02/2025
Actual
14/03/2025
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
60
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318308 0
Commercial sector/Industry
Name [1] 318308 0
Natural Remedies Pvt Ltd
Country [1] 318308 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 320693 0
Commercial sector/Industry
Name [1] 320693 0
Natural Remedies Pvt Ltd
Address [1] 320693 0
Country [1] 320693 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316943 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 316943 0
Ethics committee country [1] 316943 0
Australia
Date submitted for ethics approval [1] 316943 0
13/01/2025
Approval date [1] 316943 0
11/03/2025
Ethics approval number [1] 316943 0
0153E_2025

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

Contacts
Principal investigator
Name 139510 0
Dr Adrian Lopresti
Address 139510 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 139510 0
Australia
Phone 139510 0
+61 08 94487376
Fax 139510 0
Email 139510 0
[email protected]
Contact person for public queries
Name 139511 0
Adrian Lopresti
Address 139511 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 139511 0
Australia
Phone 139511 0
+61 08 94487376
Fax 139511 0
Email 139511 0
[email protected]
Contact person for scientific queries
Name 139512 0
Adrian Lopresti
Address 139512 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 139512 0
Australia
Phone 139512 0
+61 08 94487376
Fax 139512 0
Email 139512 0
[email protected]

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.