跳至主要内容
临床试验/CTRI/2022/07/044348
CTRI/2022/07/044348尚未招募不适用

Clinical Metabolomics investigation of Rheumatoid Arthritis patients receiving Ayurvedic whole system intervention

State Ayurvedic College and Hospital Lucknow1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月8日最近更新:

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)

研究者

发起方
State Ayurvedic College and Hospital Lucknow
申办方类型
Government medical college

研究点 (1)

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