NCT05392842已完成1 期
The Potential of Corchorus Olitorius Seeds Buccal Films for Treatment of Recurrent Minor Aphthous Ulcerations in Human Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- treatment of ulcer
研究概览
简要总结
A methanol extract of Corchorus olitorius edible plant was perpared for extration of glycosideal compounds. the extract was tested for its efficacy as antiinflammatory and analgesic activity invitro and approved by the biomarkers. a fast dissolvinf mucoadhesive film was prepared by a certain amounts of highly safe polymers for a pilote study on human for treament of Aphthous Ulcerations. two groups of study, placebo and intrvention will be recurited and followed for pain, erthymia and size of ulcers for 6 days.
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)
盲法说明
double blind masking
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18-65 years old
- •Willingness to participate and sign the informed consent forms
- •Presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter
- •An expectation that their ulcers normally take 5 or more days to resolve without treatment
排除标准
- •A known history of serious drug hypersensitivities
- •Pregnancy and lactation (Urine hCG-positive)
- •Concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions
- •A history of an immunologic problem
结局指标
主要结局
treatment of ulcer
时间窗: 6 days
ulcer size by the investigator, the diameter measured as the distance between two oppisit points of the wight area of ulcer
次要结局
- Erthymia(6 days)
- Pain scoring(6 days)
研究者
Soad Ali
Clinical professor
Deraya University
研究点 (2)
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