跳至主要内容
临床试验/CTRI/2024/11/076780
CTRI/2024/11/076780尚未招募不适用

Ocular toxicity profile of hydroxychloroquine(HCQ) and its association with blood levels :A hospital based pilot study in north east India

Phulen Sarma1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年11月27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
110
试验地点
1
主要终点
To find the ocular toxicity

研究概览

简要总结

Hydroxychloroquine is given to patients with arthropathy associated with autoimmune diseases. However, hydroxychloroquine use is associated with ocular toxicity. In this observational study, we want to study the ocular toxicity profile of hydroxychloroquine and relationship between HCQ blood levels with ocular toxicity profile.

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

  • 1.Patients suffering from autoimmune disease attending General medicine OPD and on HCQ.
  • Patient on stable daily dose of HCQ for at least 6 months
  • Age of 18 to 60 yrs would be included in the study.
  • Both sex Male and Female.

排除标准

  • Patients with pre-existing retinal diseases
  • Media opacity obscuring retinal evaluation.
  • Patient not cooperative for visual field evaluation.
  • Pregnant and lactating woman.
  • eGFR lover than 60 ml/min, chronic alcoholism and liver failure.

结局指标

主要结局

To find the ocular toxicity

时间窗: Single time point while attending the OPD

profile of hydroxychloroquine

时间窗: Single time point while attending the OPD

in patients attending

时间窗: Single time point while attending the OPD

Rheumatology clinic on HCQ

时间窗: Single time point while attending the OPD

therapy.

时间窗: Single time point while attending the OPD

次要结局

  • To find the association between(HCQ blood level & ocular)

研究者

发起方
Phulen Sarma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Phulen Sarma

AIIMS Guwahati pharmacology

研究点 (1)

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