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临床试验/NCT04693000
NCT04693000Unknown2 期

Use of Topical Solasodine of Solanum Melongena Peel Origin in the Treatment of Palmar Arsenic Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月23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
20
试验地点
1
主要终点
Arsenical Keratotic nodular size of the palm

研究概览

简要总结

Arsenic is one of the largest mass poisonings in Bangladesh. Arsenic keratosis of the palm and sole is a common feature of arsenicosis. Brinjal or eggplant ubiquitous vegetable found in different parts of the world, including Bangladesh, scientifically known as Solanum melongena. A study showed ointment containing crude extract of Solanum melongena peel origin is effective in arsenic keratosis. Solasodine is one of the active compounds of Solanum melongena peel. In the current study, an ointment containing a single compound solasodine isolated from Solanum melongena peel . The ointment made from solasodine extract was distributed among arsenic keratosis patients to see the effect.

详细描述

About millions of Bangladeshi people are chronically exposed to high arsenic concentrations (above 50 micrograms/liter) through contaminated drinking water and thus suffer from arsenic-related health hazards called arsenicosis. Arsenic keratosis is one of the commonest skin manifestations of arsenicosis that occur in the palm and sole that is troublesome for the working people and females suffered a negative socio-economic impact.

Two studies were conducted in the same department where topical ointment prepared from the crude extract of S. melongena peel was found effective in arsenical keratosis.

The present study was conducted to confirm the previous study and identify that solasodine isolated from S. melongena peel is responsible for the cure of the lesions of arsenical keratosis. Thus, it may be possible for the chemical synthesis of solasodine, and an effective, inexpensive topical ointment can be prepared for the cure of arsenical keratosis.

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
18 Years 至 60 Years(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 18 years or more than 60 years
  • Pregnant and nursing mother
  • Skin diseases like atopic dermatitis eczema and psoriasis
  • Patient allergic to brinjal (eggplant)
  • Patient taken any treatment of arsenicosis for the last six months

研究组 & 干预措施

Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment

Experimental

An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.

Keratotic nodular size observation after 12 weeks

干预措施: Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment (Drug)

结局指标

主要结局

Arsenical Keratotic nodular size of the palm

时间窗: 12 weeks

Keratotic nodular size or 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

Dr Mohammad Sazzad Hossain

MBBS, MD(Phase B) Resident

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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