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临床试验/ACTRN12621000656831
ACTRN12621000656831招募中未知

Effects of an ashwagandha extract (KSM-66) on memory, attention, energy, and sleep in children: a randomised, double-blind, placebo-controlled, multi-national study

Clinical Research Australia0 个研究点目标入组 80 人开始时间: 2021年5月31日最近更新:

试验速览

阶段
未知
状态
招募中
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
6 Years 至 12 Years(—)
性别
All

入选标准

  • 1. Parent-reported concerns in child’s attention, concentration, or memory
  • 2. Child attends mainstream schooling and mainstream classing
  • 3. Child is a healthy male or female 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 take prescribed supplements
  • 6. Child’s BMI between 18 and 30 kg/m2
  • 7. There is no plan for the child to commence new treatments over the study period
  • 8. Parent and child fluent in English

排除标准

  • 1. Current or 12-month history in a child of any psychiatric disorder (including ADHD)
  • 2. Child is currently taking pharmaceutical medications expected to affect behaviour and learning.
  • 3. Current or history of clinically significant chronic medical condition in the child including but not limited to cardiovascular disease, organic brain disorder, seizure, or diabetes.
  • 4. Any diagnosed learning disorder in the child
  • 5. Child is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc).
  • 6. Child is currently taking ashwagandha or other supplements that may affect cognition or sleep
  • 7. Child has had a significant surgery over the last year

研究者

发起方
Clinical Research Australia

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