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临床试验/CTRI/2023/03/050498
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

发起方
Dr Vibha Karande

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