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临床试验/CTRI/2022/08/044961
CTRI/2022/08/044961尚未招募3 期

Effect of hydroxychloroquine therapy in newly diagnosed type 1 diabetes: a randomised, double-blind, placebo-control pilot trial

Post Graduate Institute of Medical Education and Research PGIMER Chandigarh0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Patients with type 1 diabetes mellitus between 8 and 18 years. AND
  • 2.Detected to have type 1 diabetes mellitus in the last 100 days. AND
  • 3.Informed consent for the study given by parent or a legal guardian.

排除标准

  • Patients with any one of the following will be excluded:
  • 1.Those children who were already started on hydroxychloroquine for a different indication
  • 2.Those who had history of any serious adverse effects/ acute drug reaction after initiation of hydroxychloroquine in the past
  • 3.Patients on medications which can cause drug interactions with hydroxychloroquine
  • 4.Past history of hemolysis due to deficiency of G6PD
  • 5.Proven retinal disease in the past
  • 6.Prolonged QT interval or other known cardiac diseases
  • 7.Any active infections
  • 8.White blood cell counts less than 3000 leukocytes per microlitre, Platelets below 1,25,000/micro litre, absolute neutrophil count below 1500 per micro litre
  • 9.Liver dysfunction (jaundice, elevated alanine aminotransferase or aspartate aminotransferase for more than a week at the time of enrolment)
  • 10.Renal dysfunction
  • 11.Any ECG abnormality

研究者

发起方
Post Graduate Institute of Medical Education and Research PGIMER Chandigarh

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