A clinical study to evaluate the effect of siravedha on knee osteoarthritis and pro-inflammatory biomarkers
试验速览
- 阶段
- 3 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.
研究概览
简要总结
Osteoarthritis is a very common joint disease characterized by destruction of joint cartilage. It is produced by mechanical stress over the joint and it manifests as swelling, stiffness and joint pain. Osteoarthritis of knee is a leading cause of chronic disability in elderly, prevalence of knee osteoarthritis rises with age and is more in females than in males. The knee joint is most complex and largest joint of the body and is most vulnerable to damage because it is a mobile and weight-bearing joint. Knee osteoarthritis is one of most common form of arthritis in synovial joints. Synovial membrane inflammation plays an important role in 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 sign and symptoms of Sandhigatavata told in A**yurveda literature such as SandhiShula and Shoth in affected joints. In contemporary science a wide range of treatment modalities are available such as anti-inflammatory, analgesics, calcium and vitamin D supplements, steroids and physiotherapy but have limited prognosis due to side effects after prolonged use. So, there is need of more treatment modalities to manage sign and symptoms of knee osteoarthritis. Ayurveda offers various treatments forSandhigatavata. There is no lasting treatment available for knee osteoarthritis and Acharya Carak**a mentioned that if the disease is not treatable with all the treatment methods explained for that disease, then we should treat it as Raktaj Vyadhi. Acharya Charak**a described Raktamokshana in Raktaj Vyadhi*.Acharya Sushruta mentioned Siravedha inVatavedan.* Siravedha is an important surgical intervention in shalya tantra, Acharya Sushruta described alone Siravedha as Chikitsa-Ardha half treatment in Shalya Tantra.Ayurveda emphasizes evaluation of patients in totality for perfect diagnosis and management of disease. Acharya Caraka and Acharya Sushruta recommended extensive guidelines for assessment of disease and diseased.Prakriti assessment is a part of Dashavidha Pariksha. Prakriti is the nature of the body in terms of the Dosha and is decided at the time of conception according to the predominance of Dosha. Prakriti of patients also plays an important role in deciding treatment modalities. This study is specially planned to see effect of Siravedha on knee osteoarthritis and to see change in inflammatory markers in blood afterSiravedha.
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 patients as per Kellgren and Lawrence classification system.
排除标准
- •Rheumatoid arthritis, Gouty arthritis, osteomyelitis and septic arthritis of knee joints, local infection or skin diseases on the proposed site of Siravedha, Patients suffering from cardiovascular diseases, HIV, hepatitis, diabetes mellites, hypertension, Anemia and bleeding disorders.
- •Contraindications for Siravedha.
- •History of surgical intervention on knee joint.
结局指标
主要结局
Change in symptoms of knee osteoarthritis.
时间窗: 21days
Change in WOMAC scale.
时间窗: 21days
Change in Pro-inflammatory biomarkers in blood after Siravedha in knee osteoarthritis.
时间窗: 21days
次要结局
- Identification of type of the Prakriti most vulnerable to Knee Osteoarthritis.(Change in quality of life of the patient.)
研究者
Dr. Bharati Samota
National institute of Ayurveda , Jaipur
