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临床试验/NCT06490289
NCT06490289已完成不适用

Clinical Efficiency of Natural Herbal Based Gel in the Management of Oral Ulcer.

Pakistan Institute of Medical Sciences2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2023年6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
202
试验地点
2
主要终点
Reduction in size of Oral Ulcer and recovery of oral mucosa

研究概览

简要总结

This clinical trial was conducted in School of Dentistry, Islamabad from 15th June 2023 to 16th January 2024. A total 202 participants took part in study and were divided equally into two groups i.e Control group and Experimental group where Control group was not given any treatment for oral ulcer whereas Experimental group was given herbal based Denpro oral gel 2-4 times a day for at least 4 weeks topically on ulcer area. Mouth ulcer size in patients was measured on first day " Visit=0", second day " Visit=1", third day " Visit=2", fourth day " Visit=3", seventh day " Visit=4" and fourteenth day " Visit=5" for reduction and complete recovery. Data was analyzed by One way ANOVA and POST HOC Tukey test.

详细描述

This clinical trial was conducted in School of Dentistry, Shaheed Zulfiqar Ali Bhutto medical university for the period of six months from 15th June 2023 to 16th January 2024. Ethical approval was taken from the Ethical Review Board committee of the hospital with the Letter # SOD/ERB/2023/43-01. The participants volunteered in the study after the brief explanation about the aims and objectives study. These participants were enrolled in the study after receiving their informed written consents. Total 202 participants took part in the study and did show up during the entire follow up period of the study. 54 males and 148 females participated in this clinical trial after their confirmation of not having allergy to any type of medication. These patients were divided into two groups i.e Control group and Experimental group. Control group was not given anything but Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) for treating the ulcer 2-4 times a day for at least 2 weeks. They were instructed to apply the gel topically on the ulcer area with the help of finger or applicator after the meals or before sleeping. Moreover, they were forbidden to use any other medication for the treatment of the oral mouth ulcer to avoid the bias. Mouth ulcer size in both the control group and Experimental group was measured on the first day " Visit=0" which was taken as the baseline, again measured on second day " Visit=1" , third day " Visit=2" , fourth day " Visit=3" , seventh day " Visit=4" and finally, fourteenth day " Visit=5". These multiple visits were carried out for checking the reduction in its size and complete recovery of the oral mucosa without using anything in Control group and after the application of the gel in the Experimental group.

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 36 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mouth ulcer size greater than 2mm that appeared within 48 hours.

排除标准

  • Mouth ulcer size lesser than 2mm that did not appear within 48 hours.

结局指标

主要结局

Reduction in size of Oral Ulcer and recovery of oral mucosa

时间窗: treatment of the ulcer 2-4 times a day for at least 2 weeks.

Mouth ulcer size in both the control group and Experimental group was measured on the first day " Visit=0" which was taken as the baseline, again measured on second day " Visit=1" , third day " Visit=2" , fourth day " Visit=3" , seventh day " Visit=4" and finally, fourteenth day " Visit=5"

次要结局

未报告次要终点

研究者

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

Afsheen Mansoor

Principal Investigator

Pakistan Institute of Medical Sciences

研究点 (2)

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