Comparison Of Efficacy Of Topical Coconut, Licorice, Purslane Cream with Topical Triamcinolone Acetonide Gel for the Treatment of Oral Lichen Planus. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Topical coconut, licorice, purslane cream is efficacious in management of oral lichen planus.
研究概览
简要总结
A detailed case history will be taken from all the participants and will be recorded in the prepared proforma after patients written consent and approval from the Institutional Ethics Committee. Only those patients who are willing to participate will be considered in the study .
Total 40 clinically diagnosed patients with Oral Lichen Planus will be enrolled in the study.
Group A patients (20 subjects) will be instructed to apply Coconut, Licorice, Pruslane cream over the affected site 3 times a day, for 90 days. Patients will be ask to refrained from eating and drinking for 15 minutes post application of gel.
Group B patients (20 subjects) will be instructed to apply topical triamcinolone acetonide gel over the affected site 3 times a day, for 90 days. Patients will be ask to refrained from eating and drinking for 15 minutes post application of gel.
Pre-operative pain intensity will be measured. This clinical parameters will be measured and recorded at baseline before treatment and on days 14, 30, 60 and 90 days. Patients will be recalled for follow-up.
The intensity of pain will be recorded using a Visual Analogue Scale ranging from 0-10 where 0 denotes no pain and 10 denotes unbearable pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed oral lichen planus patients.
- •Healthy patients without any systemic diseases.
- •Patients who are ready to quit the habit if any present and accept regular follow up protocol.
排除标准
- •Patient with known history of hypersensitivity to Coconut cream, Licorice, pruslane and topical 0.1% triamcinolone acetonide gel.
- •Patient who will be diagnosed to have other intra oral lesions.
- •Pregnant women and lactating mothers.
- •Patient previously undergone treatment for oral lichen planus.
结局指标
主要结局
Topical coconut, licorice, purslane cream is efficacious in management of oral lichen planus.
时间窗: Baseline, 14th day, 30th day, 60th day and 90th day
次要结局
- Topical coconut, licorice, purslane cream is more efficacious compared to topical triamcinolone acetonide gel.(Baseline, 14th day, 30th day, 60th day & 90th day)
研究者
Dr Disha Alhat
Swargiya dadasaheb kalmegh smruti dental college and hospital, Nagpur