Evaluation of risk factors and serological determinant ( anti PGL1) in Lepra Reactions in tertiary care institute
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To determine risk factors in lepra reactions
研究概览
简要总结
Leprosy is a chronic infectious disease caused by Mycobacteria leprae and is one of the major public health problem in India. Lepra reactions are autoimmune reactions mediated against lepra bacilli which presents as systemic inflammatory complications in the form of medical emergencies which are mainly of two types: Type 1 ( Reversal Reactions) and Type 2(Erythema Nodosum Leprosum).
The risk factors associated with leprosy are not very clearly defined. Various studies have tried to identify clinical, epidemiological and laboratory risk factors for lepra reactions. They found out that old age, poor nutritional status, low BMI, coinfections, multi bacillary patients, patients with leukocytosis, thrombocytopenia, anemia were at increased risk for the development of leprosy reactions. Anti PGL1 (Phenolic Glycolipid 1) seropositivity showed greater chances for development of leprosy reactions and its level also showed a prognostic value in type 2 leprosy reactions. So far there has been no study to identify risk factors for leprosy reactions from Chhattisgarh where leprosy is endemic.
Our objective is to determine risk factors and Anti PGL1 antibody levels in leprosy reactions.
This is a cross sectional analytical study consisting of two groups of 30 patients each where group I will include leprosy patients without leprosy reactions and group II will include leprosy patients with leprosy reactions. The study will be conducted over a period of one and half years.
A detailed history will be noted, examination and relevant investigations will be conducted for all patients fulfilling the inclusion criteria and after obtaining valid written consent. Then 5ml of venous blood will be taken for the estimation of PGL1 levels using ELISA kits. The clinic-epidemiological and laboratory parameters including Anti PGL1 levels will be compared in the two groups.
Data will be entered in a excel sheet and will be analyzed using appropriate statistical tests.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •All leprosy patients (both new and old).
排除标准
- •Pregnant and lactating females Patients not willing to participate.
结局指标
主要结局
To determine risk factors in lepra reactions
时间窗: Baseline
Age
时间窗: Baseline
Gender
时间窗: Baseline
Socio-economic status
时间窗: Baseline
Spectrum of leprosy
时间窗: Baseline
次要结局
- To determine Anti- PGL1 levels(6months)
研究者
Dr Ayush Bhatnagar
All India Institute of Medical Sciences, Raipur
