Evaluation of the Efficacy of Supplementary Probiotic Capsules With Topical Clobetasol Propionate 0.05% in the Treatment of Oral Lichen Planus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- size wound
研究概览
简要总结
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups
-The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks.
Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment .
Patient's visits was at baseline, 2 weeks and 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus.
- •Male or female patient with age range between 20-75 years old were included.
- •medically free individuals
排除标准
- •the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study.
- •Pregnant females
- •patients with history of systemic disorder affecting the immune system
- •active liver diseases and cancer
- •allergy or intolerance to probiotics.
- •any other oral lesions
研究组 & 干预措施
systemic probiotic (A)
Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
干预措施: Probiotic Blend Oral capsules (Drug)
systemic probiotic (A)
Systemic probiotic capsules will be given twice daily in addition to topical application of topical clobetasol in orabase twice daily
干预措施: Corticosteroids for Local Oral Treatment (Drug)
topical corticosteroid (B)
topical clobetasol in orabse application will be given 4 times daily ( 3 times after meals and once before bed time) prophylactic topical antifungal will be given in the fourth week to prevent candidal infection
干预措施: Corticosteroids for Local Oral Treatment (Drug)
结局指标
主要结局
size wound
时间窗: 0 , 2 weeks and 4 weeks
thongprasom scale
Pain in oral cavity
时间窗: 0 , 2 weeks and 4 weeks
Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain
次要结局
- candidal load assessment(0 and 4 weeks)
研究者
Amira Abdelwhab
lecturer
October 6 University