Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- oral ulcer severity
研究概览
简要总结
The goal of this randomized clinical trial is to to compare the effect of topical rebamipide to topical betamethasone on oral ulcer severity in patients with Behcet's disease.. The main question it aims to answer is :
What is the effect of topical Rebamipide mouthwash compared to topical betamethasone mouthwash in management of oral ulcers in Behcet's disease?
Participants will will be divided randomly into the two groups and the following outcomes will be measured:
The oral ulcers severity Pain associated with oral ulcers Number of oral ulcers Healing time of oral ulcers
详细描述
This is a Randomized clinical trial (RCT) parallel groups, two arm, equivalence framework with 1:1 allocation ratio which is based on the hypothesis that Topical rebamipide has comparable effect to topical betamethasone on oral ulcer severity in patients with Behcet's disease The participants in this study will be recruited from the Rheumtology Clinic, Kasr el ainy hospital by HL as well as Oral Medicine Clinic and the dental Diagnostic center, Faculty of Dentistry, by MB. The eligible participants will be enrolled in the study in a consecutive order till the sample size is achieved.
Simple randomization will be generated using computerized random number generator (random.org) with allocation ratio (1:1).
Allocation concealment will be done using sequentially numbered opaque sealed opaque containers of the same shape, size and colour until interventions are assigned.
The entire procedure will be explained to the patients and a written consent will be obtained by the operator.
Participants and care givers will be blinded as both topical rebamipide and topical betamethasone mouthwashes will be of same consistency and will be provided in sealed opaque containers of the same shape, size and colour.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the allocation of the participants to the groups will be concealed . The bottles of both mouthwashes will be the same. The solution of both mouthwashes will be of the same colour, odor and consistency.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Behcet's disease as defined by the revised International Criteria for Behcet's Disease (ICBD2014).
- •Patients with active oral ulcers.
- •Patients free from any visible oral lesions other than the oral ulcers of BD.
- •Patient who will agree to participate in the study and take the supplied interventions.
排除标准
- •Patients with history of a severe or chronic medical condition including congestive heart failure, malignancy and active infection including tuberculosis, hepatitis and human immunodeficiency virus.
- •Patients who refuse to sign the informed consent.
研究组 & 干预措施
Rebamipide mouthwash
Rebamipide mouthwash will be administered four times daily for one week or till healing
干预措施: Rebamipide mouthwash (Drug)
Betamethasone mouthwash
Betamethasone mouthwash of will be administered four times daily for one week or till healing
干预措施: Betamethasone mouthwash (Drug)
结局指标
主要结局
oral ulcer severity
时间窗: During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.
oral ulcer severity score (OUSS). OUSS indicates the disease activity in recurrent oral ulcers., as the change in the numerical score reflects the change in ulcer severity in response to treatment
次要结局
- healing time of oral ulcers(During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.)
- Pain associated with oral ulcers(During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.)
- Number of oral ulcers(During the first week (days 1, 3, and 7), then every week for 3 weeks, afterward every month for 2 months.)
研究者
Mostafa Belal Omar Marzouk
Principal investigator
Cairo University