Clinical evaluation of siddha herbal formulation of perungaya legiam (internal) with lagu vishamutti thylam (external) in the management of thandagavatham (lumbar Spondylosis) in patients reporting at ayothidoss pandithar hospital , national institute of siddha, chennai- 600 047
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement of Aberdeen low back pain scale scoring before & after treatment.
研究概览
简要总结
INTRODUCTION:
This is a clinical trial that evaluates the effectiveness of siddha formulations perungaya legiam (internal) with Lagu vishamutti thylam (external) in the management of Thandagavatham (lumbar spondylosis) patients through Aberdeen low back pain scale. Lumbar spondylosis is a degenerative disc disease and osteoarthritic change in the lumbar spine.Lumbar spondylosis occurs as a result of new bone formation in areas where the anular ligament is stressed .Growth of new bone projecting horizontally at these margins identifies osteophytes. Lumbar osteophytes have long been thought to cause back pain because of their frequency and size.Lumbar spondylosis occurs in 6-10% of the general population and has been found to be as high as 25 -60% in athletes, especially in athletes younger than 18 years who participate in sports that involve twisting or backward bending motions of the spine. In the United States, more than 80% of individuals older than 40 years have lumbar spondylosis. Lumbar osteophytes have been found to be present in about 20% of men and 22% of women aged 45-64 years and in 30% of men and 28% of women aged 55-64 years.So my aim is to treat thandagavatham with siddha medicines.
OBJECTIVE:
• To assess the effectiveness of PERUNGAYA LEGIAM (Internal) with LAGU VISHAMUTTI THYLAM (External) in the management of THANDAGAVATHAM (LUMBAR SPONDYLOSIS) by using Aberdeen low back pain scale before and after treatment .
• The standardization of the trial drug will be done as per PLIM guidelines.
MATERIALS AND METHODS:
A total of 30 diagnosed patients of thandagavatham within the age limit of 18 to 60 years willing to particupate in the study , by signing the consent form will be enrolled in the study . Having Ankylosing spondylitis, Tuberculosis ,Hypertension ,Diabetes mellitus ,Cardiac disease and renal diasease ,Pregnant and lactating women, history of Severe injury will be excluded from the study. Assesssment will be done by using Aberdeen low back pain scale pre and post treatment.
RESULTS AND DISCUSSION: The results will be statistically analysed.
KEYWORDS: Perungaya legiam ,Lagu vishamutti thylam , Thandagavatham
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 14.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with symptoms like pain and/or stiffness of the back, pain over the front of the thigh.
- •Willing to give the blood samples for the investigation .
- •Willing to take radiological investigations .
- •Willing to sign the informed consent form.
排除标准
- •Known case of Ankylosing spondylitis
- •Uncontrolled Diabetes mellitus.
- •Pregnant and lactating women 4.Known history of Severe injury 5.Not willing to give blood samples for the investigation.
结局指标
主要结局
Improvement of Aberdeen low back pain scale scoring before & after treatment.
时间窗: 18 months
次要结局
未报告次要终点