Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000844347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
25/06/2026
Date registered
Help: Date registered
13/07/2026
Date last updated
Help: Date last updated
3/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled study to evaluate the efficacy of a Shatavari (Asparagus racemosus) extract in men experiencing self-reported stress and fatigue
Scientific title
A randomised, double-blind, placebo-controlled study to evaluate the efficacy of a Shatavari (Asparagus racemosus) extract in men experiencing self-reported stress and fatigue
Additional trial identifiers [1] 314617 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stress 342577 0
Fatigue 342578 0
Sleep disturbance 342581 0
Condition category
Condition code
Mental Health 338725 338725 0 0
Other mental health disorders
Alternative and Complementary Medicine 338726 338726 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Randomised and equal allocation to either (1) Shatavari (Asparagus racemosus) extract (500 mg - 1 capsule taken orally, once daily, after breakfast for 8 weeks), or (2) Shatavari (Asparagus racemosus) extract (300 mg) + Bioperine (5mg) (1 capsule taken orally, once daily, after breakfast for 8 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 8.
Intervention code [1] 334546 0
Treatment: Other
Description of the comparator or control
A matching placebo in terms of taste and appearance, and containing all ingredients except the active ingredient (Shatavari or Bioperine). One rice-flour capsule taken orally, once daily after breakfast for 8 weeks. Adherence to capsule intake will be measured by a count of capsules returned at week 8.
Control group
Placebo

Outcomes
Primary outcome [1] 345936 0
Stress
Timepoint [1] 345936 0
Day 0 (the day before commencement of intervention), 28 and 56 (primary endpoint) post-intervention commencement
Primary outcome [2] 345937 0
Fatigue
Timepoint [2] 345937 0
Day 0 (the day before commencement of intervention), 28 and 56 (primary endpoint) post-intervention commencement
Secondary outcome [1] 463824 0
Depressive symptoms
Timepoint [1] 463824 0
Day 0 (the day before commencement of intervention), 28 and 56 post-intervention commencement
Secondary outcome [2] 463825 0
Anxiety
Timepoint [2] 463825 0
Day 0 (the day before commencement of intervention), 28 and 56 post-intervention commencement
Secondary outcome [3] 463826 0
Sleep Disturbance
Timepoint [3] 463826 0
Day 0 (the day before commencement of intervention), 28 and 56 post-intervention commencement
Secondary outcome [4] 463827 0
Interest in Sexual Activity
Timepoint [4] 463827 0
Day 0 (the day before commencement of intervention), 28 and 56 post-intervention commencement
Secondary outcome [5] 463828 0
Total testosterone
Timepoint [5] 463828 0
Day 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [6] 463829 0
Free testosterone
Timepoint [6] 463829 0
Day 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [7] 463830 0
High-sensitivity C-reactive protein
Timepoint [7] 463830 0
Day 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [8] 463831 0
Stress
Timepoint [8] 463831 0
Day 0 (pre-commencement of intervention) and every day for 56 days (post-intervention commencement)
Secondary outcome [9] 463832 0
Fatigue
Timepoint [9] 463832 0
Day 0 (pre-commencement of intervention) and every day for 56 days (post-intervention commencement)
Secondary outcome [10] 463833 0
General wellbeing
Timepoint [10] 463833 0
Day 28 and 56 days post-intervention commencement
Secondary outcome [11] 463834 0
Heart rate variability
Timepoint [11] 463834 0
Days 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [12] 463835 0
Bioimpedance phase angle
Timepoint [12] 463835 0
Days 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [13] 463836 0
Grip strength
Timepoint [13] 463836 0
Days 0 (the day before commencement of intervention) and 56 post-intervention commencement
Secondary outcome [14] 467343 0
Oestradiol
Timepoint [14] 467343 0
Day 0 (the day before commencement of intervention) and 56 post-intervention commencement

Eligibility
Key inclusion criteria
1. Males aged 40 to 65 years.
2. Experiencing self-reported stress as indicated by a Perceived Stress Scale-4 total score of at least 6 at screening.
3. Experiencing self-reported fatigue as indicated by a PROMIS Fatigue raw score of at least 9 at screening.
4. BMI between 18 and 35 kg/m2.
5. Willing to maintain pre-screening diet, exercise, and supplement regimen during the study period.
6. Non-smoker.
7. No plan to commence new treatments over the study period.
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
65 Years
Sex
Males
Healthy volunteers
No
Key exclusion criteria
1. Clinically significant infection that has not resolved for at least 1 month before the screening visit
2. Has a recently diagnosed or unmanaged medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, gallbladder disease, autoimmune disease, renal disease, endocrine disease, or cancer/ malignancy
3. Has a psychiatric disorder (other than mild-to-moderate depression and/or anxiety), or a neurological condition/ disease, including but not limited to Parkinson’s or Alzheimer’s disease
4. Regular medication intake, including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
5. In the last 4 weeks before screening, commenced or changed pharmaceutical medications or has an expectation to change during the study period.
6. In the last 4 weeks before screening, commenced or changed over-the-counter supplements that may affect the treatment outcomes
7. Any significant surgeries over the last year that continue to affect daily function or planned surgery during the study period
8. Alcohol intake greater than 14 standard drinks per week
9. Current or 12-month history of regular illicit drug use
10. Work or home conditions that may impact sleep or energy (e.g., shift worker or regularly waking children)
11. Participation in any other clinical trial in the last 4 weeks

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
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
8/02/2027
Actual
Date of last data collection
Anticipated
12/04/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319177 0
Commercial sector/Industry
Name [1] 319177 0
Sabinsa Corporation
Country [1] 319177 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 321644 0
Commercial sector/Industry
Name [1] 321644 0
Sabinsa Corporation
Address [1] 321644 0
Country [1] 321644 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317761 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 317761 0
Ethics committee country [1] 317761 0
Australia
Date submitted for ethics approval [1] 317761 0
01/05/2026
Approval date [1] 317761 0
09/06/2026
Ethics approval number [1] 317761 0
0167E_2026

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

Contacts
Principal investigator
Name 142050 0
Dr Adrian Lopresti
Address 142050 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142050 0
Australia
Phone 142050 0
+61 8 94487376
Fax 142050 0
Email 142050 0
[email protected]
Contact person for public queries
Name 142051 0
Adrian Lopresti
Address 142051 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142051 0
Australia
Phone 142051 0
+61 8 94487376
Fax 142051 0
Email 142051 0
[email protected]
Contact person for scientific queries
Name 142052 0
Adrian Lopresti
Address 142052 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142052 0
Australia
Phone 142052 0
+61 8 94487376
Fax 142052 0
Email 142052 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 Primary Sponsor

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
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.