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临床试验/NCT02908581
NCT02908581已完成2 期

Randomized, Open Label Trial of Iron and Folic Acid on Change of Fungal Pattern

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Changes in the type of fungus in skin surface

研究概览

简要总结

This study will be conducted to observe any change in fungal pattern on skin of arsenicosis patients before and after administration of iron (150 mg) and folic acid (0.5 mg) tablets.

详细描述

Arsenicosis is remaining as a precarious issue in Bangladesh for the last few decades. The fact of resentment is that this perilous condition still remains unresolved worldwide. So, it has become the demand of era to address this issue. Different diseases are manifested in different way. In arsenicosis melanosis and keratosis are the most common manifestations. The actual mechanism of development of keratosis is unclear. Chronic ingestion of arsenic contaminated water causes accumulation of arsenic in keratin rich tissues like skin, hair, nail and producing characteristic skin manifestations like melanosis and keratosis. Metabolism of arsenic depends on folate pathway and dietary deficiency of folic acid reduced the total arsenic excretion and leads to development of cancer. In different study results shown that folic acid reduces the blood arsenic level. As arsenicosis is a chronic disease condition, fungal infection is more common to them. Moreover the skin fungal pattern in arsenicosis yet not known. Therefore, this study will be conducted to determine is there any change in skin fungal pattern in patients with palmar arsenical keratosis before and after administration of iron and folic acid. Forty two patients with palmar arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Twenty one patients will be furnished tablet placebo once daily for 12 weeks without any interruption. Another twenty one patients will be furnished iron (150 mg) and folic acid (0.5 mg) once daily for 12 weeks without any interruption. Water and nail samples will be collected for confirming the diagnosis. Skin sample will be collected two times (before and after giving iron and folic acid) for qualitative analysis of fungi. So, this study will determine any change in fungal pattern after administrating tablet iron and folic acid.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of drinking arsenic contaminated water(>50 μg/L) for more than 6 months
  • Patients having moderate palmar keratosis
  • Patients those voluntarily agree to participate

排除标准

  • Pregnant and lactating mother
  • Any other chronic diseases like tuberculosis, diabetes mellitus, asthma
  • Patient under treatment of arsenicosis on Criteria:

研究组 & 干预措施

Placebo

Active Comparator

21 Patients Placebo Each tablet by mouth once daily for 12 weeks

干预措施: Placebo (Drug)

Iron 150 mg and Folic acid 0.5 mg

Experimental

21 Patients Iron 150 mg and Folic acid 0.5 mg Each tablet by mouth once daily for 12 weeks

干预措施: Iron 150 mg and Folic acid 0.5 mg (Drug)

结局指标

主要结局

Changes in the type of fungus in skin surface

时间窗: [0 weeks (baseline), 12 weeks (end)] [Safety Issue: No]

Skin swab from five areas of skin (palm, dorsum of the hands, front, back of the chest and axilla) will be taken to see the changes in the type of fungus in skin surface in 12 weeks

次要结局

  • Scoring palmar arsenical keratosis([0 weeks (baseline), 12 weeks (end)] [Safety Issue: No])

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Mir Misbahuddin

Professor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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