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临床试验/NCT03635853
NCT03635853Unknown2 期

Identification of Compound Isolated From Cock's Comb and Its Effect on Arsenical Palmar Keratosis

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月16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
40
试验地点
1
主要终点
changes in keratotic nodular size

研究概览

简要总结

Arsenicosis is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to arsenicosis which is characterized by dermatological features i.e. diffuse melanosis , spotted melanosis and keratosis. Cock's comb is rich in hyaluronic acid, chondroitin sulfate A, B, C and heparin. Hyaluronic acid is a hydrophilic molecules and is a constituent of wound extracellular matrix and facilitate wound healing.This work is aimed to identify the component that is effective in palmar arsenical keratosis.

详细描述

Groundwater contamination caused by inorganic arsenic is a massive public health hazard in Bangladesh. Prolonged consumption of water containing high concentration arsenic leads to chronic arsenic poisoning which is characterized by dermatological features i.e. diffuse melanosis followed by spotted melanosis hyperpigmentation and keratosis.

Until now there is no internationally accepted treatment for arsenical keratosis. Some authors suggest long-term administration of vitamin and mineral and topical application of salicylic acid, propylene glycol and neem may be effective. Cock's comb extract contains hyaluronic acid, chondroitin sulfates A, B and C, heparin, hexosamine and water. Study with cock's comb extract in the treatment of arsenical keratosis was done in the Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University and was found effective. Therefore, the purpose of this study will be identification of compound isolated from cock's comb and its effect on palmar arsenical keratosis. After obtaining Institutional review board clearance, on the basis of inclusion and exclusion criteria, 40 patients with moderate to severe palmar arsenical keratosis will be enrolled from arsenic affected area located at Kamalla Union of Muradnagar Upazilla, Comilla. The study will be open phase II clinical trial. After enrollment, patients will be informed about the purpose as well as harmful and beneficial effects of the study. Informed written consent, detail history, clinical examination, photographs of the palm and water and nail samples will be collected before starting recruitment to confirm arsenicosis. For identification of compound present in the cock's comb thin layer chromatography and nuclear magnetic resonance will be done. Cytotoxic effects of the cock's comb extract will be analyzed by using brine shrimp assay. Cream will be prepared from cock's comb extract and supplied to the patient at an interval of 2 weeks to apply on palmar keratotic nodule with clean fingertip by rubbing gently at night for 12 weeks. Adherence of the cream and side effects will be monitored routinely through phone and during visit at field level. Improvement will be assessed by measuring the palmar keratotic nodular size with the help of slide calipers. The mean score of the nodular size before and after treatment will be done. Statistical analysis will be conducted by paired t test. The result will be presented in tabulated forms and bar diagrams.

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

  • drinking arsenic contaminated water (>50 microgram/litre) for more than 6 months patients with moderate to severe arsenical palmar keratosis patients voluntarily agreed to participate patient did not receive topical application of any drug for the last three months

排除标准

  • patient who received any treatment of arsenicosis within last three months patient with diagnosed skin disease, like-atopic dermatitis and psoriasis any diagnosed systemic diseases, inflammatory disease and infectious condition that affect the skin, for example- diabetes mellitus, SLE and hepatitis

研究组 & 干预措施

patients with palmar arsenical keratosis

Experimental

patients are given an ointment containing extract from cock's comb twice daily for three months

干预措施: drug containing extract from cock's comb (Drug)

结局指标

主要结局

changes in keratotic nodular size

时间窗: three months

palmar arsenical keratosis will be measured before and after applying interventions

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. Hazera Sharmin

Resident, Dept. of Pharmacology

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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