跳至主要内容
临床试验/NCT07080190
NCT07080190已完成不适用

Assessment of the Role of Early Urine Alkalinization and N-Acetylcysteine Administration in the Management of Hair Dye (Paraphenylene Diamine) Intoxication

South Valley University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Mean difference of the serum creatinine

研究概览

简要总结

This study aimed to determine the role of early urine alkalinization and N-acetylcysteine administration for the prevention of renal damage following hair dye intoxication

详细描述

Paraphenylenediamine (PPD) is an organic compound with the formula C6H4(NH2). It is the derivative of aniline, which is a white substance that turns black on oxidation, called paraphenylaniline, which is soluble in hydrogen peroxide.

Intoxication with hair dye (PPD) has become a standard method of intentional self-harm in some parts of Africa and Asia because it is cheap and readily available in the market(5).

It can cause contact dermatitis in susceptible individuals. The glutathione (GSH) levels are depleted in PPD poisoning. The antioxidant GSH plays a vital role in the maintenance of cell viability, DNA replication, and the regulation of immune cell functions. N-acetylcysteine (NAC) acts as an antioxidant both directly as a glutathione substitute and indirectly as a precursor for glutathione.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes.
  • Patients presented acutely to the emergency department with an evident history and clinical features of hair dye intoxication

排除标准

  • Renal disease.
  • Hepatic disease.
  • Diabetes mellitus.
  • Hypertension.

研究组 & 干预措施

Study group

Experimental

Patients received early N-Acetylcysteine.

干预措施: Early N-Acetylcysteine (Drug)

Control group

Active Comparator

Patients received late N-Acetylcysteine.

干预措施: Late N-Acetylcysteine (Drug)

结局指标

主要结局

Mean difference of the serum creatinine

时间窗: Immediately after N-Acetylcysteine Administration (Up to 1 hour)

Mean difference of the serum creatinine was recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Om koulthoum Mahmoud Abozeid Soliman

Assistant Lecturer of Forensic Medicine and Clinical Toxicology, Faculty of Medicine, South Valley University, Qena, Egypt.

South Valley University

研究点 (1)

Loading locations...

相似试验