An Exploratory clinical trial to assess the efficacy of Brahmi Ghrita in Mild Cognitive impairment (MCI)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1) To evaluate efficacy of Brahmi Ghrita in Mild Cognitive impairment (MCI) in Elderly people.
研究概览
简要总结
Mild Cognitive Impairment (MCI )is the most commonly observed disease amongst elderly people and it is responsible for developing the diseases like Dementia and Alzheimer’s disease(AD) (1) MCI is the most important stage between normal ageing and dementia. Prevalence of MCI observed globally is 15.56%(2). The high conversion rate from MCI to AD places a large burden on individual and family. Thus, it is a need of time to pay attention to the treatment of MCI. Comorbidities especially Hypertension and Diabetes aggravates MCI in elderly people therefore it needs to get controlled.
According to Sharangadhara Acharya, Medha (grasping and retention power) starts declining after the fourth decade of life and this may be considered as an alarming signal for further decline of Smriti (memory) and Buddhi (intellect), in the successive years. Rasayana Chikitsa has a major role to play in this arena. Nootropic drugs like Guduchi, Ashwagandha, Brahmi, Shankhapushpi various ghritas have proven efficacy in cognitive domains of psychological wellbeing. Brahmi being the most effective and safe drug is chosen for the present study in the form of Brahmi Ghrita
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex having age above 50 yrs.
- •below 80yrs.
- •Patients having symptoms of Mild Cognitive impairment(MCI).
排除标准
- •Known case of Dementia, Alzheimer’s disease 2) Patients with evidence of delirium and other disturbances of consciousness 3) Patients having complications of major illness such as Liver/Kidney failure 4) Known case of Encephalopathy, Epileptic attacks, Coagulopathies, Neuromuscular diseases, Cancer, Stroke, intracranial hemorrhage, brain tumors and brain surgeries.
- •Patients using any type of psychotropic drugs.
- •Uncontrolled DM(HbA1C> 7.5) and its complications 7) Uncontrolled HTN (Systolic >160 &Diastolic>100) and it’s complications 8) Immunocompromised patients 9) patients having Hb<8 g/dl 10) Patients having Dyslipidemia especially Sr Cholesterol >220 mg/dl, Sr Triglycerides > 180 mg/dl, Sr LDL > 150 mg/dl.
- •BMI > 40 and < 18 12) Patients with physical impairment, such as walking, sitting, bladder and bowel incontinence.
结局指标
主要结局
1) To evaluate efficacy of Brahmi Ghrita in Mild Cognitive impairment (MCI) in Elderly people.
时间窗: 1 week, 4 week, 8 week , 12 week
次要结局
- to study adverse drug reaction if any(3 months)