An Etiopathological Study of Viruddha Ahara and its association to Inflammatory Biomarkers in Rheumatoid Arthritis-A Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- To record the "Viruddha Ahara" practices in the patients of R.A and healthy Controls.
研究概览
简要总结
In order to assess the Viruddha Ahara dietary practices, a previously developed and validated Questionnaire will be used with due permission, after some modification and revalidation, to include any other parameters and redefine the options of the questions in the format of food frequency questionnaire. The confounders as mentioned will be assessed in both the groups of cases and controls, using suitably drafted questions. Inputs from the experts will be obtained for the validity and the reliability of the same. The scale will be named as Viruddha Ahara Practices Assessment Scale (VAPAS).
Using validated questionnaire, by an interview process the response of the cases and controls regarding the Viruddha Ahara practices will recorded by researcher.
The responses will be recorded in a specially prepared format developed for the study.
The disease activity score of the patients will be recorded using DAS – 28 by the researcher.
The subjects from both the groups on the basis of their Viruddha Ahara practices assessment Scale score (VAPASS) will be stratified into two subgroups of High VAPASS and low VAPASS; and random samples of 40 subjects from each of the two strata from the cases and controls, Hence a total of 160 subjects will be analyzed for the levels of the AGE and inflammatory markers.
The data will then be entered in Microsoft excel using appropriate coding and will then be statistically analyzed for any significance as per the research aims and objectives.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having Age Group 18 to 45 years of both gender, religion and socio – economic status Newly diagnosed cases of RA as per the 2010 ACR (American College of Rheumatology), EULAR (European League Against Rheumatism) Criteria for Rheumatoid Arthritis criteria selected from the OPD /IPD of All India Institute of Ayurveda, New Delhi.
- •Patient who are taking Anti Inflammatory (Analgesics), steroids, will be included after a washout period of 7 -14 days Patients not under any Dietary Regulation.
排除标准
- •Patient having any other type of Arthropathy such as Neoplasm of Spine, Gout, Ankylosing Spondylitis etc.
- •Patient with Chronic Disorder like Paralysis, Cancer, Renal Failure, Hepatic Failure, Cardiac Disease, Pulmonary Tuberculosis, Diabetes Mellitus type II Patients suffering from Psychiatric illness.
- •Pregnant women and lactating mother Patient taking Antibiotic Therapy for any Systemic Illness within 2 months.
- •Patients having Severe Crippling Bone Deformity.
- •Patient who are on disease modifying anti – rheumatoid drugs (DMARDs), and Biologicals are not included in the Study.
结局指标
主要结局
To record the "Viruddha Ahara" practices in the patients of R.A and healthy Controls.
时间窗: 1.5 years
次要结局
- To record the values of AGE, and Hs CRP in the cases and controls,To explore the relationship between the Viruddha Ahara and the biomarker levels in the cases and the controls and to explore the relationship between the Viruddha Ahara and the Disease Activity Scale (DAS 28) in the cases.(1.5 years)
研究者
Dr Mansi Mathur
All India Institute of Ayurveda