Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000638437
Ethics application status
Approved
Date submitted
10/06/2025
Date registered
17/06/2025
Date last updated
22/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a herbal supplement on mood, sleep, and physical appearance attributes in women aged 50 to 70 years experiencing low mood and poor sleep: a randomised, double-blind, placebo-controlled trial
Scientific title
The effects of a herbal supplement on mood, sleep, and physical appearance attributes in women aged 50 to 70 years experiencing low mood and poor sleep
Secondary ID [1] 314621 0
None
Universal Trial Number (UTN)
U1111-1324-0163
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Mood 337756 0
Sleep 337757 0
Condition category
Condition code
Mental Health 334091 334091 0 0
Depression
Mental Health 334092 334092 0 0
Other mental health disorders
Alternative and Complementary Medicine 334093 334093 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Saffron extract (1 tablet taken orally, twice daily, with or without food, delivering 28 mg a day for 12 weeks). Adherence to tablet intake will be measured by a daily record of tablet intake using a phone application and a tablet count by the participants at week 12.
Intervention code [1] 331245 0
Treatment: Other
Comparator / control treatment
A matching placebo (containing cellulose) in terms of taste and appearance and containing all ingredients except the active ingredient (saffron extract)
Control group
Placebo

Outcomes
Primary outcome [1] 341744 0
Low mood
Timepoint [1] 341744 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 (primary endpoint) post-intervention commencement
Secondary outcome [1] 448584 0
Sleep
Timepoint [1] 448584 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [2] 448585 0
Sleep
Timepoint [2] 448585 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [3] 448586 0
Facial Skin Age
Timepoint [3] 448586 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [4] 448587 0
Physical appearance satisfaction
Timepoint [4] 448587 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [5] 448590 0
Self-estem
Timepoint [5] 448590 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [6] 448591 0
Global Impression of Change
Timepoint [6] 448591 0
Weeks 4, 8, and 12 post-intervention commencement

Eligibility
Key inclusion criteria
1. Adults (female) aged between 50 to 70 years
2. Currently experiencing low mood as demonstrated by a score of 10 to 27 on the Depression, Anxiety, and Stress Scale -21 (DASS-21) depression subscale.
3. A score greater than 75th Percentile (T-score greater than or equal to 56.5) on the PROMIS Sleep Disturbance scale
4. Non-smoker
5. BMI between 18 and 35 kg/m2
6. No plan to commence new treatments for mood, sleep, or skin quality 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
50 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving regular psychological therapy/ counselling
2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hypertension, cardiovascular disease, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
3. Have 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. Change in medication in the last 3 months or an expectation to change during the study duration
6. In the last 3 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact treatment outcome
7. Currently taking supplements containing saffron
8. Alcohol intake greater than 14 standard drinks per week
9. Current or 12-month history of illicit drug abuse
10. Planned major lifestyle change in the next 3 months
11. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period
12. Any significant surgeries that continue to affect daily function over the last year
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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by computer software
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
30/06/2025
Actual
Date of last participant enrolment
Anticipated
29/09/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319181 0
Commercial sector/Industry
Name [1] 319181 0
Pharmactive Biotech Products, SL
Country [1] 319181 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 321648 0
None
Name [1] 321648 0
Address [1] 321648 0
Country [1] 321648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317765 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 317765 0
Ethics committee country [1] 317765 0
Australia
Date submitted for ethics approval [1] 317765 0
01/05/2025
Approval date [1] 317765 0
19/06/2025
Ethics approval number [1] 317765 0
0155E_2025

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

Contacts
Principal investigator
Name 142066 0
Dr Adrian Lopresti
Address 142066 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142066 0
Australia
Phone 142066 0
+61 08 94487376
Fax 142066 0
Email 142066 0
[email protected]
Contact person for public queries
Name 142067 0
Adrian Lopresti
Address 142067 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142067 0
Australia
Phone 142067 0
+61 08 94487376
Fax 142067 0
Email 142067 0
[email protected]
Contact person for scientific queries
Name 142068 0
Adrian Lopresti
Address 142068 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 142068 0
Australia
Phone 142068 0
+61 08 94487376
Fax 142068 0
Email 142068 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [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.