CTRI/2017/08/009504尚未招募2/3 期
A comparative clinical study to evaluate the efficacy of Matra basti and Kati basti with Sahachara taila in the management of Katigraha w.s.r. to lumbar spondylosis
National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月12日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- improvement in MOLBPDI- Modified Oswestry low back pain disability index
研究概览
简要总结
This study is a open lebel parallel group trial comparing the efficacy of Matra basti(oily medicated enema) and Kati basti (local application and retention of oiil in lumbosacral region) with Sahachar taila in the management of Katigraha w.s.r. to Lumbar spondylosis. In one group Matra basti in the dose of 75 ml per day for 16 days will be given. In another group kati basti with Sahachar oil will be applied for 16 days. The trial will be conducted in National Institute of Ayurveda Jaipur India with primary outcome of improvement in modified oswestry low back pain disability index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling the diagnostic criteria[Walking disability(10m walking test),tenderness, with confirmative degenerative changes in X-rays of lumber spine AP & L view, fulfilling the Modified Oswestry low back pain disability index(MOLBPDI).].
- •Patient without any anatomical deformity -patient willing to sign the consent for study participation.
排除标准
- •Lumber carcinoma, Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Gout, Systemic Lupus Erythematosus, Tuberculosis in bone, Ankylosing Spondylosis, pregnancy, lactation or any other systemic illnesses.
结局指标
主要结局
improvement in MOLBPDI- Modified Oswestry low back pain disability index
时间窗: 30 days
次要结局
- improvement in Visual analogue scale,improvement in 10 meter walking test and improvement in lane grading of lumbar disc degeneration scale for degenerative changes.(1 month)
研究者
研究点 (1)
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