Evaluation of Psychomotor and Cognitive Functions in patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya 1 percent Jatamansi Oil Aromatherapy Lavender Oil Aromatherapy and Standard Care)
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation and comparison of Psychomotor and Cognitive Functions in Patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya
研究概览
简要总结
The volunteers will be informed about the study protocol Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated Prior to the study approval will be taken from IEC MGACHRC Salod (H) Wardha and CTRI registration will be done After selection each participant will be tested individually and selected according to selection criteria They are divided into four groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial It will include a 21 days treatment period and at Day follow up period 0th 42 nd and 63rd day
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
- 19.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •Afore said patients who are willing to give written Informed Consent & Abide Instructions .
- •Patients of either Gender having Age group Between 19-70 years and diagnosed with Thrombotic Cerebrovascular stroke through MRI Brain.
- •Patients fit for Nasya , Aromatherapy and Thrombolytic therapy.
- •No history of cognitive/psychiatric medication, no alcohol dependence,no history of lengthy surgeries and willingness to take part.
排除标准
- •Patient with Hemorrhagic Stroke.
- •Patients having Cardiac Disease like Myocardial Infarction Angina etcetra Patients having Diabetic-Neuropathy Retinopathy Pregnant and Lactating women Patient with Acute complication like Cirrhosis of liver Pancreatitis and Hypoglycemic shock Patients having uncontrolled Hypertension [Systolic Blood Pressure greater than or equal to 140 and Diastolic Blood Pressure greater than or equal to 90mmHg] and uncontrolled Diabetes Mellitus[Fasting Blood Sugar greater than 130mgdl Post Prandial Blood Sugar greater than 180 mgdl].
结局指标
主要结局
Evaluation and comparison of Psychomotor and Cognitive Functions in Patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya
时间窗: at baseline 42 day 63 day
1 percent Jatamansi Oil Aromatherapy Lavender Oil Aromatherapy and Standard Care)
时间窗: at baseline 42 day 63 day
次要结局
- To compare and evaluate Psychomotor and Cognitive Functions in patients of Chronic Thrombotic Stroke by Four Armed Parallel Study(Jatamansi Oil Nasya ,1%Jatamansi Oil Aromatherapy, Lavender Oil Aromatherapy and Standard Care)(at baseline 6 weeks 9 weeks)
研究者
Dr Apoorva Shyamsunder Pande
Mahatma Gandhi Ayurved College Hospital and research centre Salod