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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04007705
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of FM performed by the physician, according to the Rome III criteria of the American College of Rheumatology, revised in 2010;
* Ability to read and sign the Informed Consent;
* Stable dose therapy within 4 weeks before study start.
Exclusion Criteria:
* Patients with pathologies that prevent the follow-up of the given dietary protocol;
* Patients currently undergoing lactation or pregnancy;
* Prior or current clinical history of abuse of drug or other substances;
* Change of therapy during the intervention period;
* Presence of other inflammatory diseases;
* Uncontrolled medical conditions (eg. Diabetes Mellitus, decompensated heart disease, renal failure, neoplastic diseases, liver diseases).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04007705
Study Brief:
Protocol Section:
NCT04007705