跳至主要内容
临床试验/CTRI/2024/10/075228
CTRI/2024/10/075228尚未招募不适用

Evaluation of Adverse Drug Reaction Profile of Drugs Prescribed for the Treatment of Leprosy

Dr Ravi Chandra C V1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年10月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
35
试验地点
1
主要终点
Adverse drug reaction profile (prevalence, causality, severity and preventability of drug reactions) of prescribed medications in the treatment of leprosy.

研究概览

简要总结

The research aims to evaluate the side effects of medications prescribed for the treatment of Leprosy, also known as Hansen’s Disease, a chronic bacterial infectious disease affecting the skin, nerves, and respiratory tract, primarily caused by Mycobacterium Leprae or Mycobacterium Lepromatosis. Leprosy remains a public health concern, despite being declared ‘eliminated’ in India (2005), the country still accounts for over half of the world’s new leprosy cases, with the highest prevalence in Chhattisgarh. 

The introduction of multidrug therapy (MDT) by the World Health Organization (WHO) in 1981 has been effective in reducing the prevalence of leprosy, but the adverse drug reactions (ADRs) associated with the treatment remain a significant issue. These reactions can range from mild to severe and may lead patients either to stop or alter their treatment without consulting healthcare providers, potentially hindering disease management and contributing to drug resistance.

The study focuses on assessing the prevalence, causality, severity, and preventability of adverse drug reactions linked to leprosy medications and evaluates medication adherence to multidrug therapy among leprosy patients, as nonadherence can result in treatment failure and contribute to the further transmission of the disease.

The methodology involves a cross-sectional study design with a minimum sample size of 35 leprosy patients, employing enumerative sampling techniques, conducted over a year at the All India Institute of Medical Sciences (AIIMS) Raipur, focusing on patients availing the dermatology outpatient and inpatient services.

The study aims to improve leprosy treatment by providing insights into optimizing medication protocols and enhancing patient adherence, thereby contributing to global leprosy elimination efforts.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Clinically diagnosed leprosy subjects irrespective of age, gender and co-morbidities.
  • Patients completed or undergoing multidrug therapy or alternative drug regimens for paucibacillary (PB) and multibacillary (MB) leprosy.
  • Patients receiving treatment for the management of complications of leprosy.
  • Subjects willing to participate and providing the written informed consent for the study.

排除标准

  • Patients unwilling to participate and not furnishing the required informed consent for the study.

结局指标

主要结局

Adverse drug reaction profile (prevalence, causality, severity and preventability of drug reactions) of prescribed medications in the treatment of leprosy.

时间窗: 6 months

次要结局

  • Medication adherence to multidrug therapy (MDT)(6 months)

研究者

发起方
Dr Ravi Chandra C V
申办方类型
Other [Self Sponsored ]
责任方
Principal Investigator
主要研究者

Dr Ravi Chandra C V

All India Institute of Medical Sciences (AIIMS), Raipur

研究点 (1)

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