None listed
Conditions
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.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
No
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.
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
Outcome results
None listed