Effectiveness of Garlic Oil in the Treatment of Arsenical Palmer Keratosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the clinical symptom of keratosis in palm
研究概览
简要总结
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil capsule orally for 12 weeks to examine its effectiveness in reducing body arsenic load and clinical symptoms. Similar treatment with similar number of arsenic exposed controls and healthy volunteers will be included for comparison.
详细描述
Thousands of Bangladeshi are suffering from arsenic-induced keratosis affecting palms and soles. Palmer keratosis, particularly in young female, affects the socioeconomic condition. Till today there is no effective treatment.
Twenty patients of mild to moderate degree of arsenical palmer keratosis will be treated with garlic oil in soft capsule (10 mg/day) orally for 12 weeks. Similar treatment will be given to 20 arsenic exposed controls and 20 healthy volunteers for comparison. The aim of this study is to examine the effectiveness of oral administration of garlic oil to reduce body arsenic load and clinical symptoms of arsenical palmer keratosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Patients):
- •history of taking arsenic contaminated water (>50 ppb) for more than 6 months
- •patients having mild to moderate arsenical keratosis present on palm of the hand
- •patients those voluntarily agree to participate
- •Inclusion Criteria (Arsenic exposed controls):
- •family member of the patient
- •drinking arsenic contaminated water from the same source as patient
- •those voluntarily agree to participate
- •no sign/symptom of palmer keratosis
- •Inclusion Criteria (Healthy volunteers):
- •drinking arsenic safe water (<50 ppb)
- •those voluntarily agree to participate
排除标准
- •pregnancy
- •lactating mother
- •patient receiving treatment of arsenicosis
- •any other chronic disease like tuberculosis, diabetes mellitus, bronchial asthma
结局指标
主要结局
Change in the clinical symptom of keratosis in palm
时间窗: 0 week (baseline) to 12 weeks (end)
次要结局
- Change in biochemical parameters (blood sugar, cholesterol and transaminase) after treatment(0 week (baseline), 12 weeks (end))
- Adverse effects following treament(0 week (baseline), 12 weeks (end))
- Change in the amount of arsenic in nail(0 week (baseline), 20 weeks (end))
研究者
Prof. Mir Misbahuddin
Prof. and Chairman, Department of Pharmacology
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh