A Clinical Study to Evaluate the Efficacy of Agnikarma on Knee Osteoarthritis and Pro-inflammatory Biomarkers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in symptoms of knee osteoarthritis as per WOMAC scale baseline and after treatment
研究概览
简要总结
Background: brief review of literature Osteoarthritis is a very common joint disease characterized by the destruction of joint cartilage. It is produced by mechanical stress over the joint and it manifests as swelling, stiffness, and joint pain. Osteoarthritis of the knee is a leading cause of chronic disability in the elderly, prevalence of knee osteoarthritis rises with age and is more in females than in males1. The knee joint is the most complex and largest joint of the body and is most vulnerable to damage because it is a mobile and weight-bearing joint.2 Knee osteoarthritis is one of most common form of arthritis in synovial joints. Synovial membrane inflammation plays an important role in the development of pain, joint inflammation, and cartilage destruction. Hence, pro-inflammatory mediators also play an important role in osteoarthritis. Knee osteoarthritis can be co-related with Janu Sandhigatavata because it resembles in signs and symptoms of Sandhigatavata told in Ayurveda literature such as Sandhi Shula and Shoth in affected joints.3,4 In contemporary science, a wide range of treatment modalities are available such as anti-inflammatory, analgesics, calcium and vitamin D supplements, steroids, but have limited prognosis due to side effects after prolonged use. So, there is a need for better treatment modalities to manage the signs and symptoms of knee osteoarthritis. Treatment for knee osteoarthritis in contemporary medicine begins with conservative methods and progresses to surgical treatment options when conservative treatment fails. No proven disease- modifying agents for the treatment of knee osteoarthritis currently exist. Though Knee OA is not life life-threatening condition it seriously hampers the quality of life of patients. So, when there is no definitive treatment protocol available for this condition in modern science, this study becomes crucial in finding the solution in Ayurveda in terms of Agnikarma with Shalaka.
RESEARCH QUESTIONDoes Agnikarma have any Efficacy on knee osteoarthritis and the level of the serum pro-inflammatory biomarkers?
HYPOTHESIS Null Hypothesis (H0)There is no efficacy of Agnikarma and no change in the level of the pro-inflammatory biomarkers in the blood after Agnikarma in Knee Osteoarthritis.
Alternate Hypothesis (Ha) There is an efficacy of Agnikarma anda change in the level of the pro-inflammatory biomarkers in the blood after Agnikarma on Knee Osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Grade 2 knee osteoarthritis as per Kellgren and Lawrence classification system.
排除标准
- •Patients with Rheumatoid arthritis, gouty arthritis, osteomyelitis and septic arthritis of knee joints.
- •Patients with local infection or skin diseases on the proposed site of Agnikarma.
- •Patients suffering from cardiovascular diseases, HIV, hepatitis, diabetes mellitus.
- •Contraindications for Agnikarma
- •History of trauma to knee joint.
- •History of surgical intervention on knee joint.
结局指标
主要结局
Change in symptoms of knee osteoarthritis as per WOMAC scale baseline and after treatment
时间窗: Change in symptoms of knee osteoarthritis as per WOMAC scale baseline and after treatment
次要结局
- Change in Pro-inflammatory biomarkers in blood after Agnikarma in knee osteoarthritis baseline & after treatment
研究者
Dr Sapna Yadav
National Institute of Ayurveda, Deemed to be University
