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临床试验/CTRI/2024/12/078569
CTRI/2024/12/078569已完成不适用

An observational analysis of prevalence of adverse drug reaction in a tertiary care multispecialty hospital.

Indus international hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Occurrence of adverse drug reaction at each phase of medication cycle.

研究概览

简要总结

World Health Organization (WHO) defines an adverse drug reaction (ADR) as “one which is noxious and unintended, and which occurs in doses normally used in human for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological functions.” According to the Centre for Health Policy Research, more than 50 percent of the approved drugs in the United States were associated with some type of adverse effect not detected prior to approval. At least one ADR has been reported to occur in 10 to 20% of hospitalized patients. Pharmacovigilance or ADR monitoring, launched by WHO in the 1960s in the wake of ‘thalidomide’ disaster, is currently an integrated global effort of more than 70 countries worldwide. After the “thalidomide tragedy” many countries have established drug monitoring systems for early detection and prevention of possible drug-related morbidity and mortality. The use of traditional and complementary drugs (e.g. herbal remedies) may also pose specific toxicological problems, when used alone or in combination with other drugs

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient hospitalized at IIH for treatment under: Surgical ward Oncology ward Executive ward FICU Private ward Medical ward.

排除标准

  • Patient below 18 HIV Patient and leprosy LAMA cases Medico legal cases.

结局指标

主要结局

Occurrence of adverse drug reaction at each phase of medication cycle.

时间窗: At discharge.

次要结局

  • Awareness of Adverse drug reaction in each phase of medication use cycle.(Post discharge.)

研究者

发起方
Indus international hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Palak Arya

Indus International Hospital

研究点 (1)

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