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临床试验/NCT01731756
NCT01731756已完成不适用

Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Changes in palmer arsenical keratosis

研究概览

简要总结

Effects of leaf extract of Azadirachta indica in palmer arsenical keratosis: Randomized, double-blind, placebo-control trial

详细描述

The objective of this study is to evaluate the effectiveness of topical administration of the Leaf of Azadirachta indica in the treatment of palmer arsenical keratosis. Fifty patients of moderate palmer arsenical keratosis patients from an arsenic affected area will be recruited on the basis of inclusion and exclusion criteria and had been drinking arsenic contaminated water for more than six months. They will be divided into two groups each will consist of twenty five members. One group will be provided A. indica plus 6% salicylic acid ointment to apply on palm overnight daily for 12 weeks. Another group will be provided 6% salicylic acid ointment . Water and nail sample will be collected before starting recruitment to confirm diagnosis. Then again nail sample will be collected before and after the study to see the level of arsenic in skin. Effects will be observed after every two weeks and change will be detected as nil, mild reduction, moderate reduction and fully cured.

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
Double (Participant, Investigator)

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

  • Palmer arsenical keratosis
  • Drinking arsenic contaminated water (>50 ppb) for more than six months
  • Patient voluntarily agree to participate

排除标准

  • Pregnancy
  • Lactating mother
  • Diabetes mellitus
  • Rheumatoid arthritis
  • Systemic lupus erythematosus
  • Psoriasis
  • Bowen's disease

研究组 & 干预措施

Palmer arsenical keratosis (study)

Experimental

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

干预措施: Leaf extract of A. indica (Other)

Palmer arsenical keratosis (study)

Experimental

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

干预措施: Salicylic Acid (6%) (Drug)

Palmer arsenical keratosis (study)

Experimental

Leaf extract of A. indica plus salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

干预措施: Petroleum jelly (Other)

Palmer arsenical keratosis (control)

Placebo Comparator

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

干预措施: Salicylic Acid (6%) (Drug)

Palmer arsenical keratosis (control)

Placebo Comparator

Salicylic acid (6%) in petroleum jelly base will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks

干预措施: Petroleum jelly (Other)

结局指标

主要结局

Changes in palmer arsenical keratosis

时间窗: 0 week (baseline), 12 weeks (end)

Size and number of keratotic lesions will be reduced. These will be expressed in score.

次要结局

  • Changes in arsenic level in nail(0 week (baseline), 12 weeks (end))

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

Prof. and Chairman

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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