跳至主要内容
临床试验/CTRI/2021/06/034122
CTRI/2021/06/034122尚未招募不适用

Clinical and immunological profile of systemic lupus erythematosus with special emphasis on neutrophil lymphocyte ratio and mean platelet volume as markers of disease activity.

DR Manjunath Hande1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2021年6月20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
123
试验地点
1
主要终点
To have good study about the clinical characteristics of patients of SLE presenting to the hospital

研究概览

简要总结

SLE is a systemic autoimmune disease of unknown etiology with varied clinical and laboratory characteristics, it can potentially cause substantial physical and functional disability, ranging from a rash to renal failure or even death. There is a lack of SLE registries from INDIA, which poses as a major barrier to understand patient and disease characteristics. To predict the SLE flare, we currently have a 24 parameter SLEDAI score, but no single lab test exists to recognize the flare and increase in SLE disease activity. Several studies suggest that people with active SLE have neutrophilia and lymphopenia***.*** The presence of Anti lymphocyte antibody is important in the mechanism of lymphopenia in SLE. Platelet activation is observed in patients with SLE due to inflammatory cytokines and complement. There occurs consumption of large activated platelets in extravascular sites of inflammation. In this study we will understand the profile of SLE in patients presenting to a tertiary care hospital and we will correlate the role of NLR and MPV in identifying the SLE flare. Also, NLR and MPV are readily available even at a PHC, thus increasing the chances of identifying the SLE flare at every level of healthcare.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients >18-year-old diagnosed as SLE with new ACR and EULAR criteria/ SLICC criteria.

排除标准

  • Patient with sepsis/other active infections Overlap syndromes with other rheumatological diseases Acute/chronic kidney disease (other than lupus nephritis) Leukaemia, lymphoma, malignancies Vasculitis Acute MI, Acute stroke Patients on systemic steroids >5mg/day Uncontrolled diabetes HbA1c > 7%.

结局指标

主要结局

To have good study about the clinical characteristics of patients of SLE presenting to the hospital

时间窗: At baseline

To know the immunological profile of patients of SLE

时间窗: At baseline

次要结局

  • significant increase in neutrophil lymphocyte ratio in people with active SLE(significant reduction in mean platelet volume in patients with active SLE active SLE based on SLEDAI score)

研究者

发起方
DR Manjunath Hande
申办方类型
Other [individual]

研究点 (1)

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