Clinical Trial on evaluation of regenerative effect of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata (Lumbar Spondylosis)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MRI of LS spine
研究概览
简要总结
Background: Lumbar spondyloses (LS) is characterized by degenerative changes in the spine, intervertebral disc or facet joints, vertebral body sclerosis, and hypertrophy of spinal column ligaments and others. It will contribute the society with an economical, effective, and safe alternative to conventional medicine and thus avoiding the burden of spine surgeries. Panchakarma therapies are the choice of modalities for the treatment of degenerative disorders especially lumbar spondylosis. Aims and objectives: 1.To evaluate the regenerative effect of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata using radiological parameter 2. To evaluate the efficacy of Madhutailika Basti and Ashwagandha Taila Kati Basti in Katigata Vata using Roland Morris Disability Questionnaire (RMDQ) and Numeric Pain Rating Scale (NPRS). Methods and materials: Randomized open-labeled uncontrolled clinical trial using Black Box design**.** The trial will be carried out on sixty patients of Katigata Vata with Panchakarma Interventions Kati Basti with Ashwagandha Taila, Local massage with Ashwagandha Taila, Madhutailika Basti and Cap Gandha Taila orally for 2 months. Patients will be done baseline and follow-up assessment using MRI and RMDQ, NPRS, Schober’s test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient having clinical features of low back pain worsens on long-standing and sitting stiffness, and restricted movement for more than 1 year with radiological evidence of Lumbar Spondylosis such as disc dehydration, disc narrowing, posterior disc protrusion,anterior disc herniation, disc extrusion (bulge), disc sequestration, and disc migration.
- •30 to 60 years of age irrespective of sex, religion and race will be selected.
排除标准
- •Patients having severe degeneration of the spine, tumors of the spine, tuberculosis of the spine, and severe spinal injury
- •Patients having neurological deficit due to spinal canal stenosis, spinal malignancy, Cauda equina syndrome, sciatica
- •Patients having systemic inflammatory disorders, fracture
- •Patients having uncontrolled Type 2 DM, Uncontrolled HTN
- •Patients unfit for Niruha Basti.
结局指标
主要结局
MRI of LS spine
时间窗: baseline and at the end of trial
次要结局
- Secondary Outcome measure – RMDQ, NPRS, Schober’s Test