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临床试验/NCT04963829
NCT04963829已完成1 期

Unripe Banana Peel Powder and Lemongrass Oil in Chronic Ulcer

Universidade do Vale do Sapucai2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年2月2日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Delimitation of the wound area

研究概览

简要总结

To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers.

详细描述

Purpose: To evaluate the activity of a gel composed of 10% peel powder of unripe banana (Musa sapientum) combined with lemongrass (Cymbopogon citratus) oil, at 0.1% concentration, in patients with chronic ulcers. Methods: This is a clinical, individual, analytical, interventional, longitudinal, prospective, controlled study with convenience sampling. Three groups will be used, as follows: control group 1 (CG1) with 7 participants will be treated with collagenase, control group 2 (CG2) with 7 participants will be treated with a gel composed of 10% unripe banana peel powder, and study group (SG) with 11 patients will be treated with the abovementioned gel combined with lemongrass oil at 0.1% concentration. The ulcer areas will be analyzed once a week for 4 weeks. Afterward, wound areas will be measured and the obtained data will be subjected to statistical analysis.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • presence of chronic ulcers,
  • 18 years of age and older

排除标准

  • Patients who had any type of allergic reaction to the study products during treatment

结局指标

主要结局

Delimitation of the wound area

时间窗: 3 month

To delimit the wound area, plastic and a fine-tipped pen will be used to outline the edge of the wound.

次要结局

  • Digitalizing drawing wounds measurements(3 months)

研究者

发起方
Universidade do Vale do Sapucai
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Rodrigues dos Anjos Mendonça

Principal Investigator

Universidade do Vale do Sapucai

研究点 (2)

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