Comparative Assessment of Efficacy of Vitamin B12 spray versus Benzydamine Hydrochloride spray in Prevention and Management of Radiation Mucositis-A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain score using visual analog scale every week for 8 weeks
研究概览
简要总结
MY AIM OF THE STUDY IS TO EVALUATE THE EFFICACY OF VITAMIN B12 ORAL SPRAY COMPARED TO BENZYDAMINE HYDROCHLORIDE SPRAY
Ø Sample size was estimated using g power analysis with effect size of 1.1, alpha error of 0.05 and 80 power total sample size achieved was 28 i.e. 14 patients per each group.
Ø A total number of 28 patients who will be undergoing radiotherapy will be randomly assigned into 2 groups i.e. GROUP A and GROUP B by simple random sampling using lottery method.
Ø Group A (STUDY GROUP) will be given vitamin B12 oral spray four times a day before the start of radiation therapy till 2 weeks after the radiation therapy.
Ø Group B (CONTROL GROUP) will be given benzydamine hydrochloride spray four times a day before the start of radiation therapy till 2 weeks after the radiation therapy.
Ø Patients in both the groups will be instructed to use the spray as advised to them i.e. four times a day for eight weeks after taking food.
Ø Follow up will be done every week to check for occurrence, progression and regression of oral mucositis symptoms are analysed and recorded using WHO oral mucositis assessment scale and visual analogue scale.
Ø The follow up assessment includes observation of mucosal changes and changes in pain sensations before and after the start of treatment and the time taken for remission of inflammation in oral mucosa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS WILLING TO PARTICIPATE IN THE STUDY PATIENTS WITH HEAD AND NECK CANCER WHO ARE PLANNED FOR RADIOTHERAPY.
排除标准
- •Patients who are not willing for the study Patients who are on ryles tube Patients who are on respiratory support.
结局指标
主要结局
Pain score using visual analog scale every week for 8 weeks
时间窗: Pain score using visual analog scale every week for 8 weeks | Erythema using WHO assessment scale every week for 8 weeks
Erythema using WHO assessment scale every week for 8 weeks
时间窗: Pain score using visual analog scale every week for 8 weeks | Erythema using WHO assessment scale every week for 8 weeks
次要结局
- TO KNOW THE EFFICACY OF VITAMIN B12 SPRAY(GIVEN FOR 8 WEEKS)
研究者
Mandapati Harshitha
Narayana Dental College and Hospital