Evaluation of the efficacy of topical neem extract in the management of Oral lichen planus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Burning sensation will be evaluated by visual analog scale.
研究概览
简要总结
Oral lichen planus (OLP) is a chronic mucocutaneous disease with variable etiologies. Literature shows weak evidence of effectiveness of variable treatment options available. Also most of them show complications after chronic use. Hence an alternative and safe approach like herbal therapy should be encouraged. Neem, considered as a wonder drug, exhibits properties which could be benificial for oral lichen planus. Hence this study is planned to evaluate the efficacy of 10% neem mouthwash in OLP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Symptomatic Patients with any clinical types and manifestations of OLP and those confirmed histopathologically will be included in the study.
- •2.Patients who have discontinued previous treatment for OLP for last six months.
排除标准
- •1.Patients younger than 16 years old.
- •2.Patients with skin lesions.
- •3.Patients with non symptomatic OLP lesions 4.Patients with lesions showing malignant or dysplasic changes.
- •5.Patients undergoing any other treatment for oral lichen planus.
- •Pregnant and nursing woman.
- •Patients having systemic problems or under any medications for the same.
- •Patients having habit of chewing tobacco and betelnut or smoking.
结局指标
主要结局
Burning sensation will be evaluated by visual analog scale.
时间窗: 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month
The severity of lesions on each side will be
时间窗: 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month
evaluated by Thongprasom criteria.
时间窗: 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month
次要结局
- Acceptability of neem mouthwash.(Total duration required to decrease the)