An open labelled randomized controlled clinical study to evaluate the effect of vardhamana balamoola rasayana in gridhrasi w.s.r to sciatica syndrome.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes in the signs and symptoms of gridrasi.
研究概览
简要总结
This study is an open labelled randomized controlled clinical study to evaluate the efficacy of balamoola rasayana and lashuna rasayana in vardhamana course in 30 patients diagnosed with gridhrasi/sciatica syndrome. The patients will be randomly divided into 2 groups of 15 each by adapting permuted block randomization method. Group A recruited subjects will be administered with vardhamana lashuna rasayana and group B recruited subjects will be administered with vardhamana balamoola rasayana .Total duration of study will be 48 days for group A and 61 days for group B. study will be conducted at Shri Dharmasthala Manjunatheshwara Ayurveda hospital kuthpady,udupi,karnataka,india. the primary outcome measures will be assesed based on changes in the signs and symptoms of gridrasi,changes in VAS scale, improvement on the basis of SLR test,bregards test, lasegues sign,bowstring test,femoral nerve stretch test,flip test and secondary outcome measures will be assessed based on the improvement in objective parameters like pain-greenough and fraser scoring method,neurological deficit assessment,assessment of functional ability-sugarbaker and barofsky clinical mobility scale,functional disability assessment-oswestry disability assessment questionnaire.Hence an effort has been planned through this clinical study evaluate the effect of vardhamana balamoola rasayana in gridhrasi.
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients fulfilling the diagnostic criteria.
- •2.Patients with or without radiological evidence-MRI,CT of disc prolapse.
- •3.Patients with or without radiological evidence-MRI,CT of lumbar spondylosis.
- •4.Patients between the age groups of 18-70 years and of either sex.
排除标准
- •1.Patients with radiological evidence of fracture of vertebrae, congenital deformities and neoplasm of spine.
- •2.Pregnancy and lactating mother.
- •3.Evidence of osteoporosis with BMD less than -2.5 4.Had participated in any clinical trial within 3 months of screening.
结局指标
主要结局
changes in the signs and symptoms of gridrasi.
时间窗: group A- 48 days | group B-61 days
changes in VAS scale
时间窗: group A- 48 days | group B-61 days
improvement on the basis of SLR test,bregards test, lasegues sign,bowstring test,femoral nerve stretch test,flip test
时间窗: group A- 48 days | group B-61 days
improvement in objective parameters like pain-greenough and fraser scoring method,neurological deficit assessment,assessment of functional ability-sugarbaker and barofsky clinical mobility scale,functional disability assessment-oswestry disability assessment questionnaire
时间窗: group A- 48 days | group B-61 days
次要结局
- objective parameters(2 weeks)
研究者
Dr.Anchumol joseph
SDM AYURVEDA MEDICAL COLLEGE AND HOSPITAL UDUPI
