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: 2017年8月25日

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

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

发起方

National Institute of Ayurveda Jaipur

申办方类型

Research institution and hospital

研究点 (1)

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