An open labelled triple arm non randomized phase II clinical trial,To compare the effectiveness of Varma Points Manipulation and Varma Thadaval Murai and chukku kashayam - III (Internal) in the management of Perasana Narambu Thabitham
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction of pain and improvement in range of movements will be assessed by Roland Morris Disability Questionnaire(RMDQ) and Paraesthesia and Numbness will be assessed by Leeds Assessment of Neuropathic symptoms and signs (LANSS)
研究概览
简要总结
This study is an open labelled triple arm non randomized phase II clinical trial to compare the effectiveness of Varma Points Manipulation(external therapy), Varma Thadaval Murai(external therapy) and Chukku kashayam-III(internal) in the management of Perasana Narambu Thabitham.
The manipulation of Varma Points will be done continuously for first one week and thrice a week for 8 to 21 days.
The Varma Thadaval Murai will be done by massaging continuously for first one week and thrice a week for 8 to 21 days.
The dosage of internal medication Chukku kashayam-III is 90 ml (BD) and will be administered before food for 21 days.
The sample size of the study is 90 which will be categorized in to 3 groups of each 30.
The first group will be given with Varma Points Manipulation only.
The second group will be given with Varma Thadaval Murai only.
The third group will be given with internal medication only.
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Back pain with sciatica.
- •2.Sciatica from Lumbar intervertebral disc herniation as confirmed by MRI and neurologic examination.
- •3.Lumbar or pelvic muscular spasm 4.Patient willing to sign informed consent document 5.patient willing for admission and stay in IPD or willing to attend OPD.
排除标准
- •1.Below 25yrs and above 65yrs 2.Spondylolisthesis 3.History of spinal operation,vertebral fracture or dislocation.
- •4.Conus medullaris syndrome 5.Cauda equina syndrome 6.Sacroilitis 7.Congenital anomalies 8.Spinal tumour 9.Pregnant women and lactating mothers 10.Patients with any other serious systemic illness 11.Patients who are having the skin disease.
结局指标
主要结局
Reduction of pain and improvement in range of movements will be assessed by Roland Morris Disability Questionnaire(RMDQ) and Paraesthesia and Numbness will be assessed by Leeds Assessment of Neuropathic symptoms and signs (LANSS)
时间窗: 21 Days
次要结局
未报告次要终点
研究者
Dr A DEEXIT THIRIVENI
Government Siddha Medical College and hospital, Palayamkottai