Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT06227858
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT06227858
Study Brief:
Protocol Section:
NCT06227858