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临床试验/NCT04608461
NCT04608461Unknown2 期

Effect of Pumpkin Seeds in the Treatment of Moderate to Severe Palmar Arsenical Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年9月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
23
试验地点
1
主要终点
Keratotic nodular size

研究概览

简要总结

Arsenicosis is a major health problem in Bangladesh. Long term exposure of arsenic causes keratosis of palm which reduce working capacity of patient. It also causes massive skin lesions like Bowen's disease which has a risk to develop squamous cell carcinoma. Pumpkin seed is well known for its antioxidant and anticancer properties. So this study will be conducted to identify the compound from pumpkin seeds and to see its outcome on keratosis.

详细描述

Contamination of groundwater by arsenic is a global problem affecting thousands of people worldwide, especially in Bangladesh, India and West Bengal. In Bangladesh, an estimated 59 administrative districts out of 64 have been affected with significantly high concentrations of arsenic. Due to arsenicosis, keratosis of palm and sole reduce the patient's working capacity and affect the socioeconomic condition. Bowen's disease, squamous cell carcinoma and basal cell carcinoma which are invasive skin lesions also caused by arsenicosis. Keratosis can be treated by various topical preparations like salicylic acid, alpha-lipoic acid, zinc, propylene glycol, garlic oil, neem leaf extract, an extract of Azadirachta indica and Solanum melongena. But these treatments require a longer time to relieve symptoms and thus reduce patient's compliance. Pumpkin seeds are rich not only in antioxidant vitamins (carotenoids and tocopherols), minerals and proteins, but also low in fat and calories. β-carotene reduces the damage of skin from the sun and it also acts as an anti-inflammatory agent. α-carotene slows the aging process, prevents tumor growth and reduces the risk of developing cataracts. Vitamin E also called tocopherols protects the cell from oxidative damage by preventing oxidation of cell membranous unsaturated fatty acid. β-sitosterol also useful to reduce blood cholesterol and to decrease the risks of some types of cancers. So this study will be conducted to see the outcome of pumpkin seed extract in moderate to severe palmar arsenical keratosis. The study will be an open phase-II clinical trial and will be conducted in Bangabandhu Sheikh Mujib Medical University and Sirajdikhan Upazila of Munshiganj District. Extract from pumpkin seeds will be collected by using 70% ethanol as a solvent and rotary evaporator. Thin Layer Chromatography (TLC) of extract will be done to identify the compound. By using brine shrimp bioassay cytotoxicity assay will be done. The ointment will be prepared from pumpkin seeds extract and supplied to each patient at an interval of 2 weeks. Each patient will be advised about applying the cream. Improvement and adverse effects will be monitored through phone calls and during the visit regularly. Clinical improvement will be assessed by measuring the palmar arsenical nodule size before and after completion of treatment and perception of patients about their improvement. Statistical analysis and results will be documented in different diagrams and in tabulated forms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of moderate to severe palmar arsenical keratosis
  • Drinking arsenic contaminated water for at least six months
  • Patient voluntarily agreed to participate

排除标准

  • Age less than 19 years or more than 65 years
  • Pregnant and nursing mother
  • Skin diseases like atopic dermatitis eczema and psoriasis

研究组 & 干预措施

pumpkin seeds extract containing cream

Experimental

Intervention-pumpkin seeds extract containing cream, dose-twice daily for 12 weeks

干预措施: Pumpkin seed extract containing cream (Drug)

结局指标

主要结局

Keratotic nodular size

时间窗: 12 weeks

Nodular size and lesion size will be measured by slide calipers

次要结局

未报告次要终点

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

Rokshana Khatun

MBBS, MD ( Phase- B ), Resident

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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