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临床试验/CTRI/2025/09/094381
CTRI/2025/09/094381招募中不适用

Evaluation of risk factors and serological determinant ( anti PGL1) in Lepra Reactions in tertiary care institute

Ayush Bhatnagar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月18日最近更新:

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

发起方
Ayush Bhatnagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ayush Bhatnagar

All India Institute of Medical Sciences, Raipur

研究点 (1)

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