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Trial registered on ANZCTR


Registration number
ACTRN12620000350921
Ethics application status
Approved
Date submitted
6/03/2020
Date registered
12/03/2020
Date last updated
22/04/2020
Date data sharing statement initially provided
12/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Saffron for the Treatment of Menopausal Symptoms
Scientific title
Effects of a saffron extract (affron) on climacteric symptoms in perimenopausal women: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 300735 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Climacteric symptoms 316559 0
Condition category
Condition code
Metabolic and Endocrine 314798 314798 0 0
Other endocrine disorders
Reproductive Health and Childbirth 314855 314855 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Perimenopausal women aged between 40 and 60 years experiencing climacteric symptoms will be randomly allocated to one of two treatment conditions for 12 weeks comprising:

Condition 1: Placebo tablets (1 tablet twice daily)

Condition 2: Saffron extract (affron) (1 tablet twice daily, delivering 28mg of saffron extract, affron)

Adherence to tablet intake will be monitored through tablet return and count.
Intervention code [1] 317058 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing cellulose or rice powder) is matched to the saffron tablets in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 323162 0
Change in climacteric symptoms as assessed by the Greene Climacteric Scale (GCS) total score
Timepoint [1] 323162 0
Weeks 0, 4, 8, 12
Secondary outcome [1] 381006 0
Change in quality of life as measured by the Short Form -36.
Timepoint [1] 381006 0
Week 0, 4, 8, 12
Secondary outcome [2] 381007 0
Change in mood as measured by the Positive and Negative Affect Schedule (PANAS).
Timepoint [2] 381007 0
Weeks 0, 4, 8, 12
Secondary outcome [3] 381010 0
Change in psychological symptoms score as assessed by the Greene Climacteric Scale (GCS)
Timepoint [3] 381010 0
Weeks 0, 4, 8, 12
Secondary outcome [4] 381161 0
Change in somatic symptoms score as assessed by the Greene Climacteric Scale (GCS)
Timepoint [4] 381161 0
Weeks 0. 4. 8. 12
Secondary outcome [5] 381162 0
Change in vasomotor symptoms score as assessed by the Greene Climacteric Scale (GCS)
Timepoint [5] 381162 0
Weeks 0, 4, 8, 12
Secondary outcome [6] 381163 0
Change in sexual function score as assessed by the Greene Climacteric Scale (GCS)
Timepoint [6] 381163 0
Weeks 0, 4, 8, 12

Eligibility
Key inclusion criteria
1. Healthy women aged 40 to 60 years
2. Reports of changes in the menstrual cycle for at least 3 months
3. Presence of climacteric symptoms for at least 3 months, with a total score greater than or equal to 16 on the GCS
4. Women with an intact uterus and ovaries
5. Medication-free for at least 3 months. Use of analgesics (once a week) and/or contraceptive pills are permissible.
6. Non-smoker
7. No plan to commence new treatments over the study period
8. Willing and able to take prescribed saffron/placebo tablets for 12 weeks
9. BMI between 18 and 35 kg/m2
10. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
40 Years
Maximum age
60 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have not had a period in the last 12 months
2. Suffering from a medical condition including but not limited to, diabetes, hyper/hypotension, cardiovascular disease, a gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder, and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
3. Any significant surgeries over the last year
4. Current or 12-month history of illicit drug abuse
5. Alcohol consumption > 14 standard drinks per week
6. Current use of supplements that may affect the climacteric syndrome
7. Currently taking saffron supplements

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)
Participants will be randomly and equally assigned to two groups (saffron and placebo). These groups are named group 1 and group 2, respectively. The research investigators and participants will be unaware of which treatment these groups represent. This computer-generated randomisation structure will comprise 8 randomly permuted blocks, containing 10 participants per block. Participant identification number (1 to 80) will be allocated according to the order of participant enrollment in the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation calculator (http://www.randomization.com).
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on previous studies on herbal ingredients for the treatment of menopausal symptoms in women, we are predicting an effect size of 0.6. Based on this, a total sample size of 72 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 80 participants, which should give us the suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:

1. Greene Climacteric Scale (GCS)
2. Quality of life measure: Short form -36 (SF-36)
3. Positive and Negative Affect Schedule (PANAS)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 305188 0
Commercial sector/Industry
Name [1] 305188 0
Pharmactive
Address [1] 305188 0
Avda.Severo Ochoa, 37 – Local 4J
28108. Alcobendas. Madrid. Spain
Country [1] 305188 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 305544 0
None
Name [1] 305544 0
Address [1] 305544 0
Country [1] 305544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305543 0
National Institute of Integrative Medicine (NIIM)
Ethics committee address [1] 305543 0
11-23 Burwood Rd
Hawthorn Melbourne VIC 3122
Ethics committee country [1] 305543 0
Australia
Date submitted for ethics approval [1] 305543 0
31/01/2020
Approval date [1] 305543 0
25/02/2020
Ethics approval number [1] 305543 0
0064E_2020

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 perimenopausal women experiencing climacteric symptoms (e.g., hot flushes, sweating, insomnia, mood changes, muscle pain, joint and back pain, vaginal dryness, urological symptoms, or sexual disorders) will be randomly assigned to receive tablets containing either a saffron extract (affron, 14mg twice daily) or a placebo for 12 weeks. We will assess changes in climacteric symptoms and quality of life through the completion of validated questionnaires.
Trial website
www.clinicalresearch.com.au/cra-studies/saffron-menopause-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100730 0
Dr Adrian Lopresti
Address 100730 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100730 0
Australia
Phone 100730 0
+61894487376
Fax 100730 0
+61894478217
Email 100730 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 100731 0
Dr Adrian Lopresti
Address 100731 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100731 0
Australia
Phone 100731 0
+61894487376
Fax 100731 0
+61894478217
Email 100731 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 100732 0
Dr Adrian Lopresti
Address 100732 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100732 0
Australia
Phone 100732 0
+61894487376
Fax 100732 0
+61894478217
Email 100732 0
adrian@clinicalresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (adrian@clinicalresearch.com.au)
What supporting documents are/will be available?
No other documents available
Summary results
No Results