跳至主要内容
临床试验/CTRI/2025/03/083189
CTRI/2025/03/083189尚未招募2 期

An Etiopathological Study Of Smriti Vibhramsha With Special Reference To Subjective Cognitive Impairment And Comparative Therapeutic Evaluation Of Amalakyadi Rasayana And Guduchyadi Rasayana In Its Management

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Changes in the score of The Cognitive Assessment Questionnaire.

研究概览

简要总结

Lifestyle changes and stressful circumstances has altered the psychological equilibrium of man. Hence, mental health promotion and management of various psychological and psychosomatic disorders are necessary. So, it is the need of the era to interpret the ancient concepts of Smriti with respect to modern medical and psychological sciences.

SCI has recently attracted renewed attention on the assumption that it could be the first notable manifestation in the preclinical stage of Alzheimer’s disease and dementia. In light of the projected increase of people living with dementia all over the world, there is a strong interest in early risk stages that may allow for early intervention or the prevention of dementia.

At present, many modern drugs which are available for various mental disorders are not safe to use because of their serious adverse effects. Ayurveda considers ageing as an inevitable part of life which can be delayed and its ill effects can be minimized by use of specific therapeutic interventions like rasayana. Rasayana has the potential to tackle the problems of neurodegeneration and its effect on cognition, thereby enhancing the quality of life of a person.

RESEARCH QUESTION a. What are the etiopathological factors contributing to Smriti vibhramsa with special reference to Subjective Cognitive Impairment in present time? b. Is there any difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smritikshaya with special reference to Subjective Cognitive Impairment?

HYPOTHESIS

Null Hypothesis [Ho]

There is no difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

Alternative Hypothesis [HA]

There is difference in the efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the patients of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

AIMS

To assess and compare the therapeutic efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

OBJECTIVES

Primary objectives To assess the comparative therapeutic efficacy of Amalakyadi rasayana and Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

Secondary objectives

To study the etiopathogenesis of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

To assess the therapeutic efficacy of Amalakyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

To assess the therapeutic efficacy of Guduchyadi rasayana in the management of Smriti vibhramsa with special reference to Subjective Cognitive Impairment.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with symptoms of Smriti vibhramsa and Subjective Cognitive Impairment will be enrolled after confirmation through Cognitive Assessment Questionnaire and MMSE.
  • Patients with courses characterized by gradual onset and continuing decline.
  • Patients with deficits represent a decline from a previous higher level of functioning.

排除标准

  • Subjects below 40 and above 70 yrs of age.
  • Subjects with any type of listed psychiatric disorders.
  • Known case of any neurological disease / Organic brain disease that accounts for the illness.
  • Known case of Epilepsy/ Schizophrenia/ Uremia Pregnant women Lactating mother Subjects suffering from severe systemic diseases like T.B., cancer etc.
  • will also be excluded.

结局指标

主要结局

Changes in the score of The Cognitive Assessment Questionnaire.

时间窗: After 45 Days

Changes in the score of The Mini Mental State Examination.

时间窗: After 45 Days

次要结局

  • Changes in the symptoms of the concerned disease.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anusree V V

National Institute of Ayurveda

研究点 (1)

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