Clinical Study Evaluating the Efficacy of Phenolic Complex k110-42 Therapy on Cognitive Functions of Children With Down Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Cognitive functions
研究概览
简要总结
The goal of this study is to evaluate the efficacy of phenolic complex k110-42 on cognitive function of children with Down syndrome
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Phenolic complex k110-42
900mg/kg oral once sachet for 6 month
干预措施: Phenolic complex k110-42 (Drug)
Neumentix
Sachet once for 6 month
干预措施: Neumentix (Drug)
结局指标
主要结局
Cognitive functions
时间窗: At baseline before any intervention, at 3 month ,at 6 month
Cognitive assessment will be assessed using Conners' Kiddie Continuous Performance Test (K-CPT).
Cognitive assessment will be assessed using the Wechsler Intelligence Scale for Children-Fourth Edition.
时间窗: At baseline before any intervention , at 3 month , at 6 month
次要结局
未报告次要终点
研究者
Haidi Sameh Ahmed Elassal
Resident
Mansoura University