Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children
ConditionCognitive Functions
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-8
SponsorMansoura University
About this trial
The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Phenolic complex k110-42
Drug900 mg/kg once oral in form of sachet for 6 month
Neumentix
Drug0 mg/kg once sachet oral for 6 month
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Phenolic complex k110-42Active comparator 1 intervention
Group B: NeumentixPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cognitive functions
Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT).
Time frame
At baseline before any intervention, at 3 month ,at 6 month2
Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition.
Time frame
At baseline before any intervention , at 3 month , at 6 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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