CTRI/2022/05/042364招募中4 期
A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Children.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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.Children (Male/female) of ââ?°Â¥5 and ââ?°Â¤12 years of age.
- •2.Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height.
- •3.Participants with screen time i.e., exposure to digital devices for minimum of 4 hours per day.
- •4.Participants who agree to maintain their usual dietary habits throughout the trial period.
- •5.Participants who agree to maintain their usual level of activity throughout the trial period.
排除标准
- •1.Participants Ã?â?? 5 or Ã?Æ? 12 years of age.
- •2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients.
- •3.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
- •4.Participants having a current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
- •5.Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries.
研究者
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