Therapeutic evaluation of Stressnil oral spray in the management of oral lichen planus- A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Reduction in the size of oral lichen planus lesion by visual assessment and photographic documentation.
研究概览
简要总结
This randomised controlled trial titled" therapeutic evaluation of Stressnil oral spray in the management of Oral Lichen planus" will be conducted in the department of oral medicine and radiology in Yenepoya dental college. the study has a total of 34 patients 17 in each group was estimated as sample size. All the participants in this study will be clinically and histologically confirmed cases of oral lichen planus. group A will be prescribed Stressnil oral spray along with routine triamcinolone acetonide 0.1%. this spray has to be spayed 5-6 times sublingual one hour prior to going to bed at night for a span of one month. group b will be prescribed triamcinolone acetonide 0.1% alone. patients will be recalled every week for a month to assess the reduction in size and pain of the patient. all the participants will be given standard modality of treatment and informed consent and will be taken from all the participants.
oral lichen planus is a chronic inflammatory condition associated that has various etiology and predisposing factors, stress is found to be one of the factors hence we are trying to treat stress using this spray as it claims to reduce stress ,modulate sleep and provide relaxation in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Biopsy confirmed Oral lichen planus cases.
- •Age > 18 years.
排除标准
- •Patient < 18 years.
- •Patients who are pregnant and lactating.
- •Medically compromised patients undergoing treatment for all systemic conditions except for blood pressure and diabetes (COPD patients, chronic kidney disease patients, liver disorder patients, etc will be excluded from the study)
- •Patients with lichenoid drug reactions(caused by drugs like ACE inhibitors, beta-blockers, diuretics, etc) and that arise due to heavy metal restorations or any drugs.
- •Histologic signs of dysplasia.
- •(participants who have malignancy/cancer and are under treatment for the same will be excluded from the study).
结局指标
主要结局
Reduction in the size of oral lichen planus lesion by visual assessment and photographic documentation.
时间窗: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks.
Reduction in symptoms/ burning sensation using NRS(numeric rating scale)
时间窗: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks.
次要结局
- Reduction in the progression of lesion.(2 weeks & 4 weeks.)
研究者
Dr Fathima Mohammed Abdul Majeed
Yenepoya Dental College And Hospital