Saffron for the Treatment of Menopausal Symptoms
- Conditions
- Climacteric symptomsMetabolic and Endocrine - Other endocrine disordersReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12620000350921
- Lead Sponsor
- Clinical Research Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 86
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.
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method