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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT07284693
Eligibility Criteria:
Inclusion Criteria:
* Children diagnosed with Down syndrome (Non disjunction Trisomy 21) based on genetic testing .
* Age between 4-8 years old .
* Down syndrome children presented with difficulties in attention or focus as reported by parents or based on prior clinical assessments.
Exclusion Criteria:
* Parents' refusal.
* Down syndrome children with other significant developmental or neurological disorders (e.g., autism spectrum disorder, epilepsy).
* Patients with any chronic illness as liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
* Presence of hypersensitivity to spearmint or any components of Neumentix (Neumentix may increase kidney or liver damage if used in large amounts).
* Use of stimulant ADHD medication or cognitive-enhancing supplements .
* IQ test less than 55%.
* Patients with hypothyroidism.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT07284693
Study Brief:
Protocol Section:
NCT07284693