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临床试验/NCT04385979
NCT04385979已完成不适用

Comparison of Curcumin and NanoCurcumin in Recurrent Aphthous Stomatitis

Shahid Beheshti University of Medical Sciences2 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Pain score

研究概览

简要总结

Recurrent aphthous ulcer is a painful inflammatory lesion with a high prevalence. Since the etiology is not clear, several strategies have been proposed to reduce pain and severity of its symptoms. Today, curcumin is considered as an herbal medicine with anti-inflammatory properties. Treatment or control of various inflammatory diseases has been proposed, but its low solubility in water has reduced bioavailability, while the use of nanoparticle pharmaceutical techniques has been able to solve these problems. Therefore, the aim of the present study was to evaluate the clinical efficacy of a new topical curcumin gel with nano-technology and compare it with 2% curcumin gel in patients with recurrent aphthous ulcers.

This randomized clinical trial was performed on 48 patients assigned to two groups (nano-curcumin gel) and (curcumin gel). Before treatment, the size of the wound and VAS were measured. After intervention, the two variables were measured again on the fourth and seventh days , then the amount of improvement was quantitatively and qualitatively compared in the two groups and a significant level of less than 0.05 was considered.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with minor and recurrent aphthous ulcer lesions within 48 hours and Aphthous like Lesions

排除标准

  • Wounds are in inaccessible areas (such as posterior palate). If a person suffers from systemic disease (through questioning the patient) Patients with turmeric allergy and any type of gel used in this study. Pregnant or lactating women .. accompany with other mucosal lesions. Do not take any other medicine while taking intervention Major or herpeti form of aphthous ulcer

结局指标

主要结局

Pain score

时间窗: one week

Pain assessment scale, visual analog scale (VAS) comprising of a 10-cm straight line among ends, with 0 representing no pain (better outcome) and 10 for intolerable pain (worse outcome)

Wound size

时间窗: one week

The ulcer size was evaluated by determining the distance between two opposed boundaries of the ulcer edge, using a periodontal probe in millimeters.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahin Bakhshi

Associate Professor

Shahid Beheshti University of Medical Sciences

研究点 (2)

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