A double blind randomized controlled trial to assess the efficacy of Aparajita tablet against Yashtimadhu tablet in mild cognitive impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- control groups.
研究概览
简要总结
Mild Cognitive Impairment is taken as the transient stage between normal ageing & Dementia and can have problems with memory, language, thinking & judgment. The chances of progression of Mild Cognitive Impairment into any form of Dementia is suggested as 3-5 times higher when compared with normal people.Hence clinical studies & proper treatments may improve symptoms or delay further progression of Mild Cognitive Impairment into Dementia.A previous study was conducted on Yaá¹£á¹imadhu cÅ«rņa and its effect was proven in Mild Cognitive Impairment. A well-known MÄ“dhya rasÄyana, AparÄjita having special mÄ“dhyaguņa property known for its nootropic & neuroprotective action is taken as the study drug since there is no scientific studies are conducted to evaluate its role in Mild Cognitive Impairment. Hence the current study is planned to compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment.40 participants satisfying the inclusion criteria will be selected from the OPD of VPSV Ayurveda College Hospital, Kottakkal and randomly divided into two groups, 20 in each group by using random number table method. In one group AparÄjita cÅ«rņa and in second group Yaá¹£á¹imadhu cÅ«rņa in a dose of 1.5 gm in Tablet form twice daily with lukewarm milk after food for 2 months will be given. Assessments will be done before treatment, after one month and two months of treatment and followed up after one month using Mini Mental Status Examination and Montreal Cognitive Assessment. Quality of life will be assessed using the WHOQOL BREF Scale before treatment, after two months of treatment and after one month of follow up. Aim of the study is to provide a better and convenient Ayurvedic management for Mild Cognitive Impairment. Primary Objective is to compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment. Secondary Objective is to compare the Quality of Life of subjects with Mild Cognitive Impairment in study and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •a) Diagnosed cases of Mild Cognitive Impairment as per DSM V diagnostic criteria.
- •b) Age between 50-70 years.
- •c) Those willing to give written consent.
- •d) Those whose MMSE Score lies between 19-
- •e) Those who diagnosed with Type II Diabetes Mellitus.
- •f) No discrimination of gender, religion and economic status.
排除标准
- •a) Subjects who have decline in cognitive functions as a result of trauma, surgery cardiovascular diseases, stroke, thyroid dysfunction, chronic kidney diseases, chronic liver diseases.
- •b) Those having major psychiatric co-morbidities.
结局指标
主要结局
control groups.
时间窗: Three months
To compare the efficacies of AparÄjita cÅ«rņa and Yaá¹£á¹imadhu cÅ«rņa in Mild Cognitive Impairment by using MMSE
时间窗: Three months
To compare the Quality of Life of subjects with Mild Cognitive Impairment in study and
时间窗: Three months
次要结局
未报告次要终点
