An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "KUSTATHI CHOORNAM"(Internal) "ERANDA THYLAM"for the treatment of THANDAGA VATHAM.

Dr S Neelavathi1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2017年5月9日最近更新: 2018年1月3日

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 40
试验地点: 1
主要终点: reducing pain in Lumbosacral region and both lower limb Reducing numbness and radiating pain

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

Phase II criteria based clinical study to evaluate the clinical efficacy of siddha polyherbal formulation Kustathi choornam 1 gram tds with hot water (Internal) and Eranda thylam 30ml (External) for the treatment of Thandaga vatham (Lumbar spondylosis) for 48 days in 40 patients during the trail period of 1 year 6 months conducted in government siddha medical college and hospital , palayamkottai , tirunelveli , tamilnadu . the primary outcome will be the Reducing pain in Lumbosacral region and both lower limb reducing numbness and radiating pain .the secondary outcome will be the evaluation of siddha diagnostic parameters .

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 20.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Patients having symptoms of Pain in the lumbar region 2.Radiating pain to buttocks and lower limbs 3.stiffness present in lumbar region 4.Exacerbation of pain on movements 5.Pain increased on forward bending 6.Tingling sensation.(Numbness) 7.Patients who are willing to give radiological investigation and provide blood for lab investigation.
•8.Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion.

排除标准

•1.Cardiac disease 2.Auto immune diseases like Rheumatoid 3.arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
•4.Spina bifida 5.Liver Disease 6.Pregnancy and lactation 7.Osteo myelitis 8.Renal Disease 9.Tuberculosis in spine 10.Patient with any other serious illness 11.Other systemic illness 12.Dislocation.

结局指标

主要结局

reducing pain in Lumbosacral region and both lower limb Reducing numbness and radiating pain

时间窗: 48days

次要结局

Evalution of siddha diagnostic parametes(48 days)

研究者

发起方

Dr S Neelavathi

申办方类型

Government medical college

研究点 (1)

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