Evaluation of Efficacy of Neem (Azadirachta Indica) Versus Triamcinolone Acetonide in the Treatment of Oral Lichen Planus: A Randomized Controlled Trial.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:
To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,
Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.
Participants:
In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with clinical & histopathological diagnosis of OLP.
- •Patient above 20 years of age.
- •Patient willing to participate in the study with informed consent.
- •Patient with recalcitrant OLP.
排除标准
- •Patient with known allergic reaction to Triamcinolone Acetonide or Neem.
- •Patients with lichenoid lesions.
- •Patients with associated cutaneous lesions.
- •Pregnant or lactating females.
研究组 & 干预措施
Neem
干预措施: Neem gel (Drug)
Triamcinolone Acetonide
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: From enrollment to the end of 3 months
Burning sensation will be evaluated with Visual Analogue scale
Thongprasom's Score
时间窗: From enrollment to the end of the 3 months
clinical severity of lesion
OLP Disease Severity Score
时间窗: From enrollment to the end of 3 months
Site, size and severity of lesion
次要结局
- Hospital Anxiety and Depression Scale(From Enrollment to the end of 3 months)
研究者
Medhana Mangaonker
Principal Investigator
Goa Dental College