Phenolic Complex k110-42 Therapy on Cognitive Functions in Down Children

Официальное название

Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome

Обзор

The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome

Подробное описание

Children with Down syndrome (DS) often face a variety of cognitive and developmental challenges. These challenges may include delays in speech, motor skills, and social-emotional development. Among these, difficulties with attention and focus are particularly prominent, making it harder for children with DS to participate in academic and everyday activities.

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.

Вмешательства

• Препарат Phenolic complex k110-42
  900 mg/kg once oral in form of sachet for 6 month
• Препарат Neumentix
  0 mg/kg once sachet oral for 6 month

Первичные конечные точки

• Cognitive functions [Срок оценки: At baseline before any intervention, at 3 month ,at 6 month]
• Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition. [Срок оценки: At baseline before any intervention , at 3 month , at 6 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07284693 · Ms.25.04.3157

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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