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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT07013058
Eligibility Criteria:
Inclusion Criteria:
* Perimenopausal women aged 40-60 years
* Presence of climacteric (menopausal) symptoms
* Diagnosis of metabolic syndrome, defined as alteration of at least 3 of the following:
* Systolic blood pressure ≥130 mmHg and/or diastolic ≥85 mmHg
* HDL cholesterol \<50 mg/dL
* Triglycerides ≥150 mg/dL
* Fasting blood glucose ≥100 mg/dL
* Uricemia \>7 mg/dL
Exclusion Criteria:
* Use of hormone replacement therapy (HRT)
* Presence of neoplastic diseases
* Presence of liver disease, kidney failure, or diabetes mellitus
* Drug or alcohol abuse
* Known hypersensitivity to Nigella sativa or any formulation component
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07013058
Study Brief:
Protocol Section:
NCT07013058