Evaluation of Clinical effectiveness of Ayurveda Multi-Modal Treatment(CCRAS-Park) in Parkinsons disease: an exploratory Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The aim of the present study is to evaluate a scientifically designed Ayurveda procedure protocol(CCRAS-Park) targeted to give deep brain stimulation and stimulation to vagal nerve fibres. The procedures hypothesized for stimulation of vagus nerve is postulated in the design to give vagal nerve stimulation and deep brain stimulation due to temperature, pressure, retention effects over a period of time activating stimulatory pathways. The procedures typically serve in stimulating vagal nerve sites are totally safe and with no complications since they are included in the daily regimen and life style advocacies in Ayurveda Preventive medicine. This protocol is hypothesized to give more sustainable results, improved QOL, patient-friendliness, cost-effectiveness compared to existing treatment strategies of DBS, VNS and nVNS. Being the most preliminary step, this exploratory pilot protocol, will open up new vistas in Ayurveda parkinsonism research and will contribute to sustainable therapeutic outcomes with no complications.
Patient screening will be done from NARIP, Cheruthuruthy from General daily OPD. Also, Parkinson’s screening camps will be conducted at NARIP frequent basis. The enrolled participants will undergo stabilization of levodopa at Jubilee Mission Medical College Hospital in day 0. The participants will undergo CCRAS-Park protocol at the IPD of NARIP, Cheruthuruthy for 30 days followed by a follow up period upto 180th day. The follow up visits will be done at 30th day, 60th day, 90th day and 180th day.
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
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants who are diagnosed with PD of greater than 2year duration and are non-ambulatory.
- •Patients those who are relatively stable during the study period and remained stable on medication in the last 2 months.
- •Willing to comply and provide written informed consent, for intervention treatment Participants receiving dopaminergic medications will be asked to continue the same up to completion of study (6 months).
排除标准
- •Prior diagnosis of dementia or mild cognitive impairment on screening MOCA 24, other psychiatric symptoms History of co morbid neurologic disorders or major cardiovascular conditions, history of deep brain stimulation or other brain surgery, neurogenic orthostatic hypotension, clinically diagnosed chronic respiratory illness, liver disease, renal disease, uncontrolled hypertension, pregnancy Any other condition that the investigator believes makes him or her unsuitable for participation in this study.
研究者
Dr Devi R Nair
National Ayurveda Research Institute for Panchakarma Cheruthuruthy