Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children
NCT ID: NCT07284693
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
108 participants
INTERVENTIONAL
2026-01-31
2026-12-31
Brief Summary
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Detailed Description
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One promising avenue for improving cognitive function is the use of natural compounds with neuroprotective and cognitive-enhancing properties. The phenolic complex K110-42 (Neumentix), derived from the extract of spearmint, has garnered attention for its potential benefits in cognitive performance.
Specifically, polyphenols contained within the aqueous extracts from the Lamiaceae family could mechanistically account for the reported benefits on cognitive performance. Polyphenols found in aqueous extracts of spearmint such as salvianolic and rosmarinic acids have been shown to have anti-oxidant, anti-inflammatory, anti-acetylcholinesterase, and neuroprotective biological activity both in vitro and in vivo .
Phenolic offers a number of benefits on cognitive functions and it is plausible that its anti-inflammatory, antioxidant, anti-fibrotic effects, enhance attention, improving vascular endothelial functions and enhancement of metabolic performances. Because of the multiple functions, phenolic has direct effects on attention deficit in DS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phenolic complex k110-42
900mg/kg oral once sachet for 6 month
Phenolic complex k110-42
900 mg/kg once oral in form of sachet for 6 month
Neumentix
Sachet once for 6 month
Neumentix
0 mg/kg once sachet oral for 6 month
Interventions
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Phenolic complex k110-42
900 mg/kg once oral in form of sachet for 6 month
Neumentix
0 mg/kg once sachet oral for 6 month
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
4 Years
8 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Haidi Sameh Ahmed Elassal
Resident
Central Contacts
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Other Identifiers
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Ms.25.04.3157
Identifier Type: -
Identifier Source: org_study_id