A Clinical Study to evaluate the efficacy of Vriddha Darak Rasayana in the Enhancement of Smriti wsr to Amnestic Mild Cognitive Impairment (aMCI)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement in Smriti in aMCI
研究概览
简要总结
To enhance cognitive function Ayurveda recommends rasayana therapy which includes medicinal herbs dietary modifications and lifestyle interventions that rejuvinate the nervous system enhance neuroplasticity and improve cognitive abilities . Vriddhadarak Rasayana a classical memory enhancing rasayana formulation is mentioned in ayurvedic text for enhancing cognition preventing neurodegeneration and restoring memory functions. It contains neuroprotective adaptogenic and anti inflammatory herbs that have been traditionally used to improve mental clarity concentration and memory retention . This study aims to evaluate the clinical efficacy of Vriddhadarak Rasayana in enhancement of Smriti wsr to Amnestic Mild Cognitive Impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •i Participants in this study will be community dwelling persons aged 35 to 60 years diagnosed persons with amnestic mild cognitive impairment using Petersons amnestic MCI Criteria ie 1 Memory Complaint Subjective response to standardized question 2 Norrmal general Cognitive function Mini Mental State Examination score more than 25 MoCA 18 to 25 3 Intact activities of daily living ADCS ADL MCI more than 51 4 No Dementia Clinical Dementia rating score less than 1 5 Impaired memory objective evidence for age and education Word List Delayed Recall score less than 1 SD below mean memory scale ii Consented individuals will be irrespective of sex caste religion and race with MCI able to write read and understand the hindi english language will be considered for the study.
排除标准
- •1 Dementia or significant cognitive impairment that interfere with daily life 2 Subjects with Alcohol use Disorders Identification Test AUDIT score more than 3 3 Pregnant women 4 Lactating mother 5 Any Systemic disorders like kidney disorders liver disorders and cardiac disorders 6 Neurological conditions like Parkinsons disease multiple sclerosis or stroke that can affect cognition 7 Psychiatric conditions like depression Schizophrenia and anxiety 8 Participants taking medications that can affect cognitive function such as sedatives and anticholinergics 9 Subjects with uncontrolled blood pressure diabetes mellitus or hypothyroidism 10 Subjects who have received treatment with any approved or investigational health supplements for improvement of cognition and memory within the past one month preceding the screening visit 11 Subjects with abnormal laboratory tests findings such as AST and ALT greater than 3 times the upper limit of normal Hb less than or equal to 8 Platelets count less than 1 lakh 12 Subjects participating in another clinical trial within the 3 months preceding the screening 13 Subjects with a history of traumatic brain injury with loss of consciousness or convulsions 14 MMSE less than 25 15 Subjects with Manda Agni.
结局指标
主要结局
Improvement in Smriti in aMCI
时间窗: 30 days
次要结局
未报告次要终点
研究者
Dr Viveka
KSVAMC RC Gangoh UP
