Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000393358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/03/2026
Date registered
Help: Date registered
27/03/2026
Date last updated
Help: Date last updated
25/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Vanizem (Aframomum melegueta seeds extract) on Stress, Anxiety, Sleep, and Mood in Adults with Mild-to-Moderate Stress.
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Trial Investigating the Effects of Vanizem (Aframomum melegueta seeds extract) on Stress, Anxiety, Sleep, and Mood in Adults with Mild-to-Moderate Stress.
Additional trial identifiers [1] 314616 0
None
Universal Trial Number (UTN)
U1111-1337-3182
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stress 341080 0
Anxiety 341081 0
Sleep disturbance 341082 0
Fatigue 341083 0
Condition category
Condition code
Mental Health 337199 337199 0 0
Other mental health disorders
Mental Health 337200 337200 0 0
Anxiety
Alternative and Complementary Medicine 337201 337201 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Aframomum melegueta seeds extract (Vanizem) (1 capsule taken orally, once daily, in the morning with food, delivering 100mg a day for 28 days). Adherence to capsule intake will be measured by a count of capsules returned on day 28
Intervention code [1] 333460 0
Treatment: Other
Description of the comparator or control
A matching placebo (containing maltodextrin) in terms of taste and appearance, and containing all ingredients except the active ingredient (Aframomum melegueta seeds extract)
Control group
Placebo

Outcomes
Primary outcome [1] 344723 0
Stress
Timepoint [1] 344723 0
Days 0 (day before commencement of intervention) and 28 (primary endpoint) post-intervention commencement
Secondary outcome [1] 458994 0
Anxiety
Timepoint [1] 458994 0
Days 0 (day before commencement of intervention), 3, 7, 14 and 28 post-intervention commencement
Secondary outcome [2] 458995 0
Mood
Timepoint [2] 458995 0
Days 0 (day before commencement of intervention), 3, 7, 14 and 28 post-intervention commencement
Secondary outcome [3] 458996 0
Fatigue
Timepoint [3] 458996 0
Days 0 (day before commencement of intervention), 7, 14 and 28 post-intervention commencement
Secondary outcome [4] 458997 0
Sleep disturbance
Timepoint [4] 458997 0
Days 0 (day before commencement of intervention), 7, 14 and 28 post-intervention commencement
Secondary outcome [5] 458998 0
Sleep
Timepoint [5] 458998 0
Day 0 (pre-commencement of intervention) and every day for 28 days (post-intervention commencement)
Secondary outcome [6] 458999 0
Mood
Timepoint [6] 458999 0
Day 0 (pre-commencement of intervention) and every day for 28 days (post-intervention commencement)
Secondary outcome [7] 459000 0
Global impression of change
Timepoint [7] 459000 0
Day 28 post-intervention commencement
Secondary outcome [8] 459001 0
Heart rate variability
Timepoint [8] 459001 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [9] 459002 0
Serotonin
Timepoint [9] 459002 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [10] 459003 0
5-hydroxyindoleacetic acid
Timepoint [10] 459003 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [11] 459004 0
Interleukin-6
Timepoint [11] 459004 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [12] 459005 0
High-sensitivity C-reactive Protein
Timepoint [12] 459005 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [13] 459006 0
Brain-derived neurotrophic factor
Timepoint [13] 459006 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [14] 459007 0
Anandamide
Timepoint [14] 459007 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [15] 459008 0
Cortisol
Timepoint [15] 459008 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [16] 459009 0
Salivary alpha-amylase
Timepoint [16] 459009 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [17] 459010 0
Secretory immunoglobulin A
Timepoint [17] 459010 0
Days 0 (day before commencement of intervention) and 28 post-intervention commencement
Secondary outcome [18] 459011 0
Liver function profile composite score (safety measure)
Timepoint [18] 459011 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [19] 459012 0
Renal function profile composite score (safety measure)
Timepoint [19] 459012 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [20] 459013 0
Complete blood count composite score (safety measure)
Timepoint [20] 459013 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [21] 459014 0
Fasting glucose (safety measure)
Timepoint [21] 459014 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [22] 459015 0
Thyroid-stimulating hormone (safety measure)
Timepoint [22] 459015 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement
Secondary outcome [23] 459016 0
Lipid profile composite score (safety measure)
Timepoint [23] 459016 0
Days 0 (pre-commencement of intervention) and 28 post-intervention commencement

Eligibility
Key inclusion criteria
1. Males and females aged 18 to 60 years
2. Experiencing self-reported stress
3. A score between 14 and 26 (inclusive) on the Perceived Stress Scale (PSS) at screening
4. Non-smoker for at least 12 months duration
5. BMI between 18 and 35 kg/m2
6. No plan to commence new treatments over the study period.
7. Understand, willing and able to comply with all study procedures.
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Suffering from a diagnosed medical condition, including but not limited to diabetes, hypertension, cardiovascular disease, adrenal disease, gastrointestinal disease requiring regular use of medications, biliary disease, thyroid disease, cancer/malignancy, renal disease, hepatic disease, endocrine disease, respiratory disease, neurodegenerative disease, or chronic/acute pain condition
2. Past gastrointestinal surgery that may affect the absorption of the investigational product
3. Current diagnosis of a psychiatric disorder, other than mild-to-moderate depression or anxiety symptoms
3. Abnormal blood makers comprising one or more of the following: fasting glucose greater than or equal to 7.0 mmol/L; TSH less than 0.4 mIU/L or greater than 4.0 mIU/L; creatinine greater than or equal to 2 times above laboratory reference range; AST or ALT greater than or equal to 3 times above laboratory reference range; or creatine kinase greater than or equal to 2 times above reference ranges
5. In the last 3 months, the regular intake of any pharmaceutical medication (excluding contraceptive medication or the occasional use of analgesics of not more than twice weekly), or an intention to start during the study period.
6. In the last 3 months, the regular intake of any over-the-counter vitamin or herbal supplement, or an intention to start during the study period.
7. Engaged in night-shift work, irregular shift work, or has experienced circadian rhythm disruption (e.g., jet lag) in the last month.
8. Planned major lifestyle or dietary change during the study duration
9. Alcohol intake greater than 14 standard drinks per week
10. Current or 12-month history of illicit drug abuse
11. Pregnant women, women who are breastfeeding, women who are less than 3 months postpartum, or women who intend to become pregnant during the study period.
12. In the last year, has had surgery that affects general health or daily function, or has a planned surgery in the next 2 months
13. Participation in any other clinical trial in the last 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)
Two randomisation strata will be created based on sex (male or female), with an equal distribution in each stratum. The randomisation table will be 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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2026
Actual
14/04/2026
Date of last participant enrolment
Anticipated
17/08/2026
Actual
Date of last data collection
Anticipated
14/09/2026
Actual
Sample size
Target
100
Accrual to date
78
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319176 0
Commercial sector/Industry
Name [1] 319176 0
Nektium Pharma SL
Country [1] 319176 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 321643 0
Commercial sector/Industry
Name [1] 321643 0
Nektium Pharma SL
Address [1] 321643 0
Country [1] 321643 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317760 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 317760 0
Ethics committee country [1] 317760 0
Australia
Date submitted for ethics approval [1] 317760 0
12/01/2026
Approval date [1] 317760 0
08/03/2026
Ethics approval number [1] 317760 0
0165E_2026

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

Contacts
Principal investigator
Name 142046 0
Dr Adrian Lopresti
Address 142046 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142046 0
Australia
Phone 142046 0
+61 8 94487376
Fax 142046 0
Email 142046 0
[email protected]
Contact person for public queries
Name 142047 0
Adrian Lopresti
Address 142047 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142047 0
Australia
Phone 142047 0
+61 8 94487376
Fax 142047 0
Email 142047 0
[email protected]
Contact person for scientific queries
Name 142048 0
Adrian Lopresti
Address 142048 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142048 0
Australia
Phone 142048 0
+61 8 94487376
Fax 142048 0
Email 142048 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?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety 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.