A Comparative study on assesing efficacy and safety of methylene blue oral rinse vs Standard therapy for treating pain from Oral Mucositis, related to cancer treatment in a tertiary care hospital-A Randomised Open labelled Prospective study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Numerical rating scale pain score will be assesed
研究概览
简要总结
To assess the efficacy and safety of Methylene blue oral rinse (0.1%) in comparison with Standard therapy for treating pain from oral mucositis related to cancer treatment (Chemotherapy/Radiotherapy/both) in a tertiary care hospital. Participants satisfying the inclusion and exclusion criteria will be randomised into 2arms.Informed consent will be obtained. Study arm will receive methylene blue oral rinse(0.1%) every 6hours for 2days.Control arm will receive salt water rinse every 6hours for 2days.Numerical rating scale and Oral Functioning burden will be assesed at baseline,day1 and day2.participants will be monitored for any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
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 with Oral mucositis receiving chemotherapy/Radiotherapy for malignancy.
排除标准
- •Patients with known history of hypersensitivity to methylene blue, pregnancy, breastfeeding mothers, cognitive impairment, not able to give consent, known documented history of G6PD deficiency, asymptomatic cases, pain due to oral ulcers /growth which are diagnosed to be malignancy.
结局指标
主要结局
Numerical rating scale pain score will be assesed
时间窗: At baseline, day1 ,day 2
次要结局
- Oral functioning burden(OFB) will be assesed(at baseline, day 1,day2)
研究者
Dr Viswanath S
Tamilnadu Dr MGR Medical university