An Open Non Randomized Clinical Trial to evaluate the therapeutic effectiveness of Milaghu Legiyam (Internal) And Kunthiriga Thailam (External) in the management of Vathasthambam (Sciatica) in patients reporting at Ayothidoss Pandithar Hospital-OPD, National Institute of Siddha.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2.Reduction in pain is assesed by using the universal Pain Assesment Scale
研究概览
简要总结
INTRODUCTION:
This is an open clinical trial that evaluates therapeutic effectiveness of siddha formulation MILAGHU LEGHIYAM AND KUNTHIRIGA THAILAM in the management of VATHASTHAMBAM (SCIATICA) patients through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment. Sciatica is a condition characterized by pain affecting the low back, hip and outer side of the leg, caused by compression of a spinal nerve root in the lower back, often owing to degeneration of an inter - vertebral disc. 5%-10% of patients with low back pain have sciatica, whereas the reported lifetime prevalence of low back pain ranges from 49% to 70%. The annual prevalence of disc related sciatica in the general population is estimated at 2.2%.
OBJECTIVE:
PRIMARY OBJECTIVE:
• To assess the therapeutic effectiveness of MILAGHU LEGHIYAM (INTERNAL) and KUNTHIRIKA THAILAM (EXTERNAL) in the management of VATHASTHAMABAM through The Modified Oswestry Low Back Disability Questionnaire and Universal Pain Assessment Scale before and after treatment.
• To evaluate the standardization of the trial drug Milaghu leghiyam and Kunthiriga thailam
SECONDARY OBJECTIVE:
• To evaluate the laboratory parameters before and after the study.
MATERIALS AND METHODS:
A Total of 30 diagnosed patients of Vathasthambam (Sciatica) within the age limit of 20-60 years willing to participate in the study, by signing the consent form will be enrolled in the study. Uncontrolled Diabetes Mellitus, K/H/O Ankylosing spondylitis, K/H/O Vertebral fracture and Spinal deformity, Cardiac diseases and Renal diseases, Pregnant and lactating women and With severe or terminal illness like CA or HIV, Not willing to sign the informed consent will be excluded. Assessment is done through improvement in The Modified Oswestry Low Back Disability Questionnaire and reduction of pain using the Universal Pain Assesment Scale before and after treatment.
RESULTS AND DISCUSSION:
The result will be statistically analyzed
KEYWORDS :
Vathasthambam, Sciatica, Milaghu Legiyam
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.Low back pain radiating to lower limb posterolaterally Numbness and paresthesia in same distribution Low back ache aggrevates after prolonged standing and walking Difficulty in bending and lifting Coughing exacerbates the low back pain etc (Any 2 or more symptoms will be included) 2.Positive SLR Test 3.Positive Lasegue Test 4.The Modified Oswestry Disability Scale a score of 40% or more will be taken 5.Patient willing to undergo radiological investigation and laboratory investigation 6.Patient willing to sign the informed consent form.
排除标准
- •1.Uncontrolled Diabetes Mellitus 2.Ankylosis Spondylosis 3.Vertebral fracture and Spinal deformity 4.Cardiac and renal diseases 5.Pregnant and Lactating mother 6.with severe and terminal illness like CA or HIV 7.Not willing to give blood samples for investigation.
结局指标
主要结局
2.Reduction in pain is assesed by using the universal Pain Assesment Scale
时间窗: 18 MONTHS
1.Improvement in the Modified Oswestry Low Back Disability Status of the patient before & after the treatment will be obtained
时间窗: 18 MONTHS
次要结局
未报告次要终点