CTRI/2021/10/037126已完成未知
Effects of KSM-66 on memory, attention, executive function, and sleep in children: a randomized, double-blind, placebo-controlled study
D Y Patil Medical College Hospital and Research Center0 个研究点目标入组 44 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Parent-reported concerns in child’s attention, concentration, or memory
- •2. Attendance to mainstream schooling and mainstream classing
- •3. Healthy males and females aged between 6 and 12 years
- •4. Parent/legal guardian and child willing to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
- •5. Child willing and able to swallow capsules
- •6. BMI between 18 and 30 kg/m2
- •7. No plan to commence new treatments over the study period
- •8. Parents and children fluent in English
排除标准
- •1. Current or 12-month history in child of any psychiatric disorder (including ADHD)
- •2. Child is currently taking pharmaceutical medications expected to affect behavior and learning.
- •3. Current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes
- •4. Any diagnosed learning disorders
- •5. Currently taking nutraceutical supplements
- •6. Children who are experiencing exceptional social/family stressors (e.g., serious illness in
- •the family, recent parental separation, etc).
- •7. Any significant surgeries over the last year.
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