Effect of standardized aqueous extract of Withania somnifera on tests of cognitive and psychomotor performance in healthy human participants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mean percentage change in reaction time in cognitive and psychomotor tests on treatment with withania somnifera extract compared to placebo
研究概览
简要总结
Background : Withania somnifera is an herbal medicine that has traditionally been attributed to memory-enhancing properties.
The current study involved an assessment of cognitive and psychomotor effects of standardized aqueous extract of Withania somnifera in healthy human participants.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Materials and Methods : In a randomized, placebo-controlled, double-blind, crossover, prospective study, 20 healthy participants received 500 mg twice daily of encapsulated dried root and leaf aqueous extract of Withania somnifera or a matching placebo for 14 days with a wash out period of 10-14-days. Cognitive and psychomotor performance was assessed predose (day1) and at 3 hrs postdose on day 15 using the battery of computerized psychometric tests.
Results : Significant improvements were observed in reaction times with simple reaction, choice discrimination, digit symbol substitution, digit vigilance and card sorting tests with Withania somnifera extract compared to placebo . However no effect can be seen with the finger tapping test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Participants willing to sign informed consent
- •Participants with normal healthy conditions- Normal vitals, Physical examination, Normal weight and height as per LIC chart No H/o of neuropsychological and psychiatric disorders.
- •Participants with normal to corrected vision.
- •Able to perform the test procedures, as per the protocol.
排除标准
- •1.H/o of psychiatric illiness, insomnia, use of any psychiatric medication.
- •2.H/o of drug dependence or any severe co-morbid medical conditions.
- •4.Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
- •5.Abnormality in routine lab investigations like complete blood picture, complete urine examination, liver function tests or renal function tests.
- •6.Participating in any drug trials/ research projects over the past 3 months.
- •7.Alcohol consumption 24 hrs before study day.
- •8.Tea/Coffee consumption or smoking 12 hrs before the study day.
- •9.Pregnant/breast feeding/ child bearing potential participants.
结局指标
主要结局
Mean percentage change in reaction time in cognitive and psychomotor tests on treatment with withania somnifera extract compared to placebo
时间窗: Baseline (Day-1) and Post Treatment(Day 15)
次要结局
- Safety and tolerability of withania somnifera extract capsules(Baseline (Day-1) and Post Treatment(Day 15))