Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated With Perimenopause in Healthy Women
Investigation of the Psychological and Physiological Effects of a Standardised Saffron Extract Supplementation on Symptoms Associated to Perimenopause in Healthy Older Women: A Randomised Double-blind, Placebo-Controlled, Parallel-group Clinical Trial
Liaquat University of Medical & Health Sciences
104 participants
Aug 20, 2025
INTERVENTIONAL
Conditions
Summary
The aim of the present study is to assess the effects of a normalised saffron extract supplementation, which is an extract of the flower Crocus sativus, on perimenopausal symptoms.
Eligibility
Inclusion Criteria6
- Biological Female which identify themselves as Women
- Aged ≥ 40 years
- Irregular menstrual cycle for at least 3 months
- Presenting typical symptoms of perimenopause with GCS score over 20
- BMI range between 18-35 kg/m2
- Healthy woman
Exclusion Criteria13
- Less than 40 years old
- Pregnant
- Diagnosed with diseases related to reproductive system such as PCOS or endometriosis
- Taking anti-depressant medication or sleeping pills
- Taking hormonal replacement therapy (HRT)
- Taking conventional drug treatment or dietary supplementation
- Having medical history or medical/surgical event in the last 6 months, or has been treated for cancer or any other ongoing treatment for the past 3 months,
- Current and/or past history of hyper/hypotension, CVD, diabetes, autoimmune diseases, musculoskeletal disorder or endocrine or immunocompromised or neurological or psychological disorders,
- Being medicated for these conditions,
- History of allergic reactions to saffron intake,
- Decisionally challenged subjects or unable to comply to the study
- Any conditions that could contraindicates the use of saffron
- Currently smoking or ceased smoking in the past 3 months
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dietary supplementation will be taken in addition to habitual diet of the patients
Placebo capsule (matched to the experimental intervention in terms of colours and taste, without the active compounds saffron)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06227858