Effects of Leaf Extract of Azadirachta Indica in Palmer Arsenical Keratosis: Randomized, Double Blind, Placebo-controlled Trial
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
- 否
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)
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)
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)
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)
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)
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
Prof. Mir Misbahuddin
Prof. and Chairman
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
