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临床试验/CTRI/2018/03/012818
CTRI/2018/03/012818招募中2 期

A prospective open labeled randomized clinical trial on "Thandaga Vatham"(Lumbar Spondylosis) with evaluation of trial drug "Veppam Pattai Kudineer"

Dr S NEELAVATHI MD PhD1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年11月9日最近更新:

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
Therapeutic efficacy of trial drug Vaeppam Pattai Kudineer for Thandaga Vatham

研究概览

简要总结

The study is A Prospective Open Labelled Phase II Randomized clinical study to evaluate the therapeutic efficacy of VAEPPAM PATTAI KUDINEER 50ml BD for 30 days in 40 patients during the trial period of 12 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug VAEPPAM PATTAI KUDINEER for THANDAGA VATHAM The secondary outcome will be the evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug

研究设计

研究类型
Interventional
分配方式
Not Applicable
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

  • Patients having symptoms of low back ache radiating to buttocks and lower limbs Pain aggrevated by forward bending Numbness in the lower extremities.

排除标准

  • Patients with Systemic Hypertension Diabetes mellitus Cardiac disease Autoimmune diseases like Rheumatoid arthritis SLE Psoriasis Congenital spinovertebral deformities Liver disease Pregnancy and lactating mother Renal diseases Tuberculosis in spine.

结局指标

主要结局

Therapeutic efficacy of trial drug Vaeppam Pattai Kudineer for Thandaga Vatham

时间窗: 30days

次要结局

  • Evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug(30 days)

研究者

发起方
Dr S NEELAVATHI MD PhD
申办方类型
Government medical college

研究点 (1)

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