A Descriptive study of Adverse Drug Reactions with Causality Assessment and Potential Drug Interactions in the Outpatients of the Psychiatric Department at SMS Hospital Jaipur.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 1. To report and evaluate patterns of Adverse Drug Reactions (ADRs) occurring due
研究概览
简要总结
Under-reporting is a problem with ADRs occurring due to psychotropic drugs. The need for this study is for observation and analysis of the ADRs occurring due to psychotropic drugs and then assessing all the reported ADRs for Causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale. Also, studying the potential drug-drug interactions (pDDIs) amongst different psychotropic drugs as well as between psychotropic drugs and other co-prescribed drugs by using Medscape software (online) (http://reference.medscape.com/drug-interactionchecker) will aid clinicians to achieve optimal therapeutic outcomes in patients by increasing awareness of clinically relevant psychotropic drug interactions. It will also help to sensitize the healthcare workers as well as the patients and their attendant for reporting of ADRs occurring due to psychotropic medications.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients attending the Psychiatric OPD for follow up, who were diagnosed to be suffering from any psychiatric illness and prescribed at least one psychotropic drug.
- •Patients of either sex.
- •Patients in the age group of 18 years to 60 years.
- •Patients who will give informed consent.
排除标准
- •Patients having mental and behavioural disorders due to psychoactive substance use.
- •Patients who are pregnant/ lactating women.
- •Patients who are part of any other study.
- •Patients who will be non-co-operative.
结局指标
主要结局
1. To report and evaluate patterns of Adverse Drug Reactions (ADRs) occurring due
时间窗: 6 Months
to psychotropic drugs.
时间窗: 6 Months
2. To assess all the reported ADRs for Causality using WHO-UMC scale.
时间窗: 6 Months
3. To study the potential drug-drug interactions (pDDIs) among different
时间窗: 6 Months
psychotropic drugs as well as between psychotropic drugs and other co-prescribed
时间窗: 6 Months
drugs by using Medscape software (online) (http://reference.medscape.com/druginteractionchecker).
时间窗: 6 Months
次要结局
- 1. To process the reported ADRs to Indian Pharmacopoeia Commission (IPC)(Ghaziabad by using VIGIFLOW software.)
研究者
Dr Kapil Goyal
SMS Medical College