Clinical Metabolomics investigation of Rheumatoid Arthritis patients receiving Ayurvedic whole system intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical metabolomic assessment and clinical outcome among the people registered under the study following the Ayurvedic whole system intervention will be done through DAS-28 ESR scoring. Final assessment will be done with the help of ACR20, ACR50 and ACR70 criteria. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.
研究概览
简要总结
Rheumatoid Arthritis (RA) is an autoimmune musculoskeletal disorder having a high prevalence and debility potential. Its treatment conventionally aims at early diagnosis followed by symptom management, deformity and joint destruction prevention, restoration of joint mobility and quality of life improvement. ’Clinical Metabolomic’ in RA is one step head of conventional assessment done through clinical observations generic biomarkers like ESR & CRP. Purpose of this study is to find if there are any meaningful differences among ’RA related disease activity specific metabolites’ in sample population of RA receiving ayurvedic whole system intervention considering its own method of diagnosis & treatment selection. Intervention will be given for 3 months. A 2 weekly follow-up will be done for the purpose of clinical records. Metabolomics will be performed only pre and post i.e., at the time of registration & after completion of trial. A patient population of 30 RA considering the single group & pragmatic nature of the study having a simultaneous diagnosis of Amavata and receiving specific ayurvedic comprehensive interventions (whole system approach) for 3 months will be evaluated clinically on the basis of DAS-28 score changes and will be categorized for level of improvements as ACR20, ACR50 or ACR70. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.
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
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients not in remission state as per DAS-28 ESR criteria.
排除标准
- •Having co-morbid conditions like Osteoarthritis, Gout etc.
结局指标
主要结局
Clinical metabolomic assessment and clinical outcome among the people registered under the study following the Ayurvedic whole system intervention will be done through DAS-28 ESR scoring. Final assessment will be done with the help of ACR20, ACR50 and ACR70 criteria. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.
时间窗: 12 weeks
次要结局
- Quality of life improvement.(12 weeks)
