The development and validation of a diagnostic tool for sÄma nirÄma differentiation in patients with Rheumatoid arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To develop a tool for assessing SÄma and NirÄma avastha in patients with confirmed diagnosis of rheumatoid arthritis.
研究概览
简要总结
Rheumatoid Arthritis is an immune-inflammatory systemic disorder with clinical signs and symp-toms mainly affecting synovial joints. Effective treatment of Rheumatoid arthritis has been ham-pered by the heterogeneity of the disease. Although early intervention can result in disease remis-sion, it requires early diagnosis and current diagnostic tests are not sufficiently accurate or sensitive in the early stages of RA. As a result, RA is typically diagnosed only once damage to the joints has already begun, a time at which the window for optimal treatment may have been missed. On the other hand Ayurveda Physicians do treat the patients of RA based on the Dosha evaluation and SÄma NirÄma differentiation. But there are difference of opinions among Ayurveda practitioners regarding the diagnosis, SÄma NirÄma Differentiation and management.
Concept of ama is a unique one which helped in understanding the disease and classifying the dis-ease in to sÄma and nirÄma avastha. In classical literature of Ayurveda, the concept of SÄmavastha and NirÄmavastha of the doshas and diseases is given importance because it plays a key role in proper management of the disease and from the diagnostic point of view. Also the line of treatment for both these stages are different from one another. Specific parameters are required to understand and confirm the prevalence of Ama, its severity and also the NirÄma stage in the body for the selec-tion of the accurate therapeutic measure. So this study is aimed to develop and evaluate a tool de-signed to understand and confirm the prevalence of Ama, its severity and also the NirÄma stage in the body which ease the task of screening and management of rheumatoid arthritis may be one of the needed interventions .The tool will be validated and grades will be included on the basis attainment of sÄma nirÄma lakshana.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients already diagnosed as Rheumatoid Arthritis as Per 1987 Revised ACR Classification Criteria · Subjects between age group 16 to 60 yrs.
- •· Patients of either sex irrespective of socioeconomic status..
- •· Patients fulfilling diagnostic criteria.
排除标准
- •History of inflammatory joint disease other than RA which might interfere the Study e.g.; Systemic lupus erythematous, ankylosing spondylitis, osteoarthritis.
- •· Subject with other major systemic illness that may interfere with the study.
- •· Patients who were under steroid therapy.
- •· Patients with tumors, metabolic diseases of bone.
- •· Heart diseases or severe hypertension, any endocrine diseases Such as hyperthyroidism, and severe infection.
结局指标
主要结局
To develop a tool for assessing SÄma and NirÄma avastha in patients with confirmed diagnosis of rheumatoid arthritis.
时间窗: Team meeting with experts 24 weeks | Questionnaire preparation 24 weeks | Using delphi method analysing the findings 12 weeks | Tool development and validation 9 months
To assess the SÄma NirÄma avastha in patients using the developed and validated tool.
时间窗: Team meeting with experts 24 weeks | Questionnaire preparation 24 weeks | Using delphi method analysing the findings 12 weeks | Tool development and validation 9 months
次要结局
未报告次要终点
研究者
DurgalakshmiS
Amrita School of Ayurveda,, Amrita Vishwa Vidyapeetam,
