Efficacy And Safety Of KSM66 Ashwagandha (Withania somnifera) In Cognitive Function In Healthy Adults: A prospective, Randomized, Double blind, Placebo controlled Study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) after therapy
研究概览
简要总结
This study is A prospective, randomized, double-blind, placebo-controlled study to compare the efficacy of Ashwagandha in improving Cognitive Function in healthy adults.
A total of 50 healthy adults subjects will be recruited in this study.
Adult male or female subjects > 35 years of age, with early dementia or mild cognitive impairment, having Mini-Mental State Examination (MMSE) score ≥19 at baseline and having subjective memory complaints will be enroll in study. Study duration will be 8 weeks for each subject with baseline, week 4 & week 8 visits. Subjects were asked to take 1 capsule two times daily (total2 capsules per day) with water daily for 8 weeks.
At the end of study primary outcome will be assessed as improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) and secondary as improvement from baseline in the Index scores of immediate memory, General memory and working memory. Improvement from baseline in the visual reproduction score, Shepard’s mental rotation task score, Eriksen Flanker task score, Wisconsin card sort test score, Trail making test part A score and Mackworth’s sustained attention test score. Global assessment of tolerability will be performed by physician at the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female patients aged greater than 35 years of age 2.Patients with early dementia or mild cognitive impairment 3.Have a screening Mini-Mental State Examination (MMSE) score of greater than or equal to 19 (mild or no memory impairment) 4.Patients with subjective memory complaints 5.Have the ability to understand the requirements of the study 6.Participants agree to abide by the study restrictions and return for the required assessments 7.Participants willing to sign informed consent.
排除标准
- •1 Have a screening Mini-Mental State Examination (MMSE) score of less than 19(moderate and severe memory impairment) 2.Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntington’s disease, Picks disease etc.
- •3.Patients taking psychotropic drugs including alcohol 4.Patients taking any other drugs or alternative medicines for enhancement of memory 5.Patients with known persistent endocrine disorders 6.Patients with uncontrolled hypertension 7.Patients with uncontrolled diabetes mellitus 8.H/o of drug dependence or any severe co-morbid medical conditions 9.Pregnant and lactating women 10.Subjects with known hypersensitivity to Ashwagandha 11.History of major surgery within the past 6 months 12.Participation in other clinical trials during previous 3 months 13.Any clinical condition, according to the investigator which does not allow safe fulfillment of the study protocol.
结局指标
主要结局
Improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) after therapy
时间窗: 8 weeks
次要结局
- Improvement from baseline in the Index scores of General memory after therapy.(8 weeks)
- Improvement from baseline in the Index scores of working memory after therapy.(8 weeks)
- Improvement from baseline in the Index scores of immediate memory after therapy.(8 weeks)
- Improvement from baseline in the score of Trail making test part A after therapy(8 weeks)
- Improvement from baseline in the score of Mackworth’s sustained attention test after therapy(8 weeks)
- Improvement from baseline in the scores of visual reproduction I and II total score, visual reproduction II Recognition Total Score, visual reproduction II Copy Total Score and visual reproduction II discrimination Total Score after therapy(8 weeks)
- Improvement from baseline in the score of Shepard’s mental rotation task after therapy(8 weeks)
- Improvement from baseline in the score of Eriksen Flanker task after therapy(8 weeks)
- Improvement from baseline in the score of Wisconsin card sort test after therapy(8 weeks)