跳至主要内容
临床试验/CTRI/2024/05/067521
CTRI/2024/05/067521进行中(未招募)不适用

Evaluation OF Adverse Drug Reactions In Patients On Antiretroviral Therapy Attending Antiretroviral Therapy Centre In A Tertiary Care Hospital Of Eastern India – A Cross Sectional Study

Government Medical College1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
144
试验地点
1
主要终点
Evaluation of Adverse Drug Reactions in Patients on Anti-Retroviral Therapy

研究概览

简要总结

In this study patients aged above 18 years on Anti Retroviral Therapy (ART) attending the ART center of R G kar Medical College and Hospital having given proper consent and fulfilling inclusion and exclusion criteria are taken into study. Adverse Drug Events occurring during therapy will be documented in respective Adverse Drug Reaction forms and causality will be assessed using the WHO-UMC causality categories assessment scale and Naranjo assessment scale. The severity of the Reaction will be assessed using the Modified Hartwig and Seigel severity assessment scale. Criteria for preventability will be assessed using the Schumock and Thronton scale. Expected outcomes in this study may be as documentation of respective Adverse Drug Reactions in patients on Antiretroviral Therapy and determination of Severity and Preventability of ADRs.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of any gender on Anti Retroviral Therapy (ART) attending ART Centre.
  • Patients of age above 18 years.

排除标准

  • Patients who disagree to give consent.

结局指标

主要结局

Evaluation of Adverse Drug Reactions in Patients on Anti-Retroviral Therapy

时间窗: At baseline

次要结局

  • i.To estimate the Severity &(Preventability of ADRs in)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Gunjan Gayen

R.G. Kar Medical College And Hospital

研究点 (1)

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