CTRI/2023/05/052880已完成Unknown
A Prospective, Randomized, Double-Blind, Placebo-Controlled,Parallel Study to Assess The Safety and Efficacy of Bacopamonnieri on Memory and Cognitive Skills in Adult Humans.
Samriddh Nutractive Pvt. Ltd.0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 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
入排标准
入选标准
- •1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive)
- •2.Refrain from taking any medications to improve memory and cognition during the study.
- •3.Healthy subjects with MMSE score of 24-30.
- •4.Willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visiting days.
- •5.Willing to refrain from consuming alcohol 24 hours prior to the visiting days.
- •6.Willing to refrain from vigorous physical activity 12 hours prior to test days.
- •7.Having basic computer literacy and exposure to computerized tests.
- •8.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Consumption of any memory improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines.
- •2.Subjects having hypersensitivity or history of allergy to the study product.
- •3.Subjects with any degree of cognitive impairment.
- •4.Subjects with sleep disturbances and/or are taking sleep aid medication.
- •5.Subjects with chronic diseases like hypertension, ischemic heart disease, diabetes, and psychiatric or CNS disorders.
- •6.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
- •7.Excessive habitual caffeine consumption ( >300 mg caffeine/day or =3 cups of caffeinated coffee/day) throughout the study period.
- •8.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •9.Positive Urine Pregnancy Test at Screening /Randomization Visit.
- •10.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •11.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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