CTRI/2023/03/050498招募中Unknown
Efficacy of Ashwagandha (Withania Somnifera) Standardized Root Extract on Accuracy and Reaction Time in Video Gamers: A Prospective, Randomized, Two-Way Crossover, Double-Blind, Placebo-Controlled Study
Dr Vibha Karande0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
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. Subjects of either gender aged 18 to 50 years.
- •2. First person shooter gaming history of >6 hours/week for > 3 months.
- •3. Body Mass Index between 16.5 to 30 kg/sq.m
- •4. Subjects who sign the informed written consent.
- •5. Subjects with history of regular sleep and agree to sleep for 8 ±1 hours the night before the visit day.
- •6. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
- •7. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
- •8. Subjects willing to refrain from consuming caffeine and caffeine-containing products 24 hour prior to visit days.
排除标准
- •1. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
- •2. Known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, haematological, or neurological illnesses.
- •3. Presence of any current psychiatric disorders that are judged by investigator as potentially
- •causing or contributing to insomnia.
- •4. Use of tobacco products.
- •5. Currently taking any medication on regular basis
- •6. Substance dependence/ abuse in the past one year or with alcohol abuse are ineligible.
- •7. History of seizures or significant head trauma.
- •8. Subjects who travelled across four or more time zones or worked on night or rotating shifts
- •in previous 7 days before study initiation or who plan to do the same during the study
- •9. Another investigational drug was used within three months prior the entry in this study.
- •10. Cannot be relied upon to comply with the test procedures or are unwilling to give informed
研究者
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