A Pilot Study to evaluate the Clinical Efficacy of an Ayurvedic Treatment Module in the Management of Multiple Sclerosis ( Sarvanga Gatavata)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in spasticity using MSSS 88 SCALE.
研究概览
简要总结
BACKGROUND:Multiple sclerosis (MS) is an autoimmune inflammatory disease in which fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination, scarring, and a broad spectrum of signs and symptoms.Myelin is a protecting and insulating sheath covering the nerves. MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other. MS is a gradual process, which goes on for weeks, months, and years. The cause remains unknown to modern science. Theories include autoimmune, genetic, infectious, and environmental factors.Based on the immune basis of MS, some treatments and drugs have been discovered with different efficacies and indications for MS which mostly suppress the immune system so myelin sheath could be saved or the patient could experience a remission course. Unfortunately, there are some adverse effects (AE)associated with these drugs which can be considered mild or even severe.These AEs make MS treatment require a careful choice between these drugs by expert neurologists according to each patient’s situation and history. All these treatments are expensive and the prognosis is very poor Hence there is a need of cost-effective treatment, which help in reducing spasticity and improves the Quality of Life in the patients . The present study is formulated to find out the combined effect of Panchakarma procedures along with Shamana aushadhi.
OBJECTIVES OF THE RESEARCH:
**PRIMARY:**1) To determine the clinical efficacy of an ayurvedic treatment module in the management of Multiple Sclerosis for reducing Spasticity in patients of 21-55 years of age.
**SECONDARY:**1) To improve the quality of life in patients with Multiple Sclerosis.
METHODOLOGY:
Sample size calculation: As no previous studies are available and it is a pilot study, the sample size will be limited to 15 only.
Sample Collection: - Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited
Total no. of days treatment given until (Shodhana) = 36 days
Total no. of days given Pratimarsha, Nasya, ShamanaAushadi = 16 days
Follow up = 90 days
Total Duration of Study = 142 days
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
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are fit to undergo Snehapana, Virechana, Swedana,Basti and Nasya Karma. 2.Diagnosed cases of Multiple Sclerosis with MRI , continuing allopathic medication and EDSS score less than
- •ICD code: G.
- •Socio- economic status: All.
排除标准
- •Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women, exposed skin related disease.
- •2.EDSS score more than 8 .
结局指标
主要结局
Reduction in spasticity using MSSS 88 SCALE.
时间窗: (Day-0) (Day-22) (Day-38) (Day-52)
次要结局
- To determine the change in Quality of life using MSQL54(instrument, Visual Analog score and EDSS.)
研究者
Dr Anagha Sudhir
All India Institute of Ayurveda