A Double-blind, Randomized, Placebo-controlled Trial of Nigella Sativa in the Treatment of Palmer Arsenical Keratosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical improvement of signs and symptoms of palmer arsenical keratosis
研究概览
简要总结
Daily intake of Nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis
详细描述
Depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. Study population will be divided randomly into two equal groups: one group will receive vitamin E capsules (200 mg) plus placebo and another group will receive vitamin E capsule plus N. sativa capsules (500 mg) twice daily for 12 weeks. Drinking water (50 mL) and urine (50 mL) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. Nail (approx. 1 g) and blood (5 mL) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. Clinical examinations will be done at regular interval (two weeks). Clinical features and adverse effects will be recorded using a structured data collection sheet. Plasma cholesterol, vitamin E, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of N. sativa on palmer arsenical keratosis patients
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
- •Moderate palmer arsenical keratosis
- •Patient drinking arsenic contaminated water (more than 0.05 mg/L) for more than six months
- •Subjects those voluntarily agree to participate
排除标准
- •Patient received treatment of arsenicosis for the last three months
- •Pregnancy
- •Lactating mother
- •Psoriasis
- •Contact dermatitis
- •Tuberculosis
- •Diabetes mellitus
- •Patients with hepatic and renal impairment
结局指标
主要结局
Clinical improvement of signs and symptoms of palmer arsenical keratosis
时间窗: up to 12 weeks
Signs and symptoms of palmer arsenical keratosis will be examined by one trained doctor at the temporary arsenic camp at regular interval (2 weeks). Another doctor will note the findings of the patient in the data collection sheet without informing the previous data to the former doctor. Signs and symptoms of moderate arsenical keratosis will be assessed by estimating the number and size of keratotic lesions and expressed into scoring.
次要结局
- Arsenic level in nails(0 week (baseline), 12 weeks (end))
- Estimation of serum vitamin E levels(0 week (baseline), 12 weeks (end))
- Estimation of serum total cholesterol levels(0 week (baseline), 12 weeks (end))
- Liver function(0 week (baseline), 12 weeks (end))
- Renal function(0 week (baseline), 12 weeks (end))
研究者
Prof. Mir Misbahuddin
Prof. and Chairman, Department of Pharmacology
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh