CTRI/2023/05/052548招募中3 期
Assessment of comparative efficacy of medicated oil pulling therapy versus Benzydamine mouthwash in post radiation mucositis of oral cancer Patients- A Pilot Study
Mahatma Gandhi Ayurveda College and Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年5月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Reduced grade of- WHO oral mucositis Score
研究概览
简要总结
In this study, Benzydamine mouthwash 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation and another group by Oil pulling Therapy 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation Patient will be assessed for WHO Oral mucositis score before and after oil pulling Therapy. Changes in the WHO Oral mucositis score will be noted. Follow-up will be taken every 15 days for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Known cases of oral cancer patients who are having symptoms of radiation induced mucositis in the age group 18-60 years (post operated or pre operated cases) and who give written consent for the study will be included like
- •RIM with Mouth ulcers
- •RIM with Dysphagia
- •RIM with Pain in buccal cavity
- •RIM with Oral thrush
- •RIM with Candidiasis
- •RIM with Plaques
- •RIM with Gingivitis
- •RIM with Controlled diabetics will be included in the study.
排除标准
- •Complicated cases of oral cancer with RIM will be excluded in the study like
- •Patients of Oral cancer with multiple sinuses
- •Uncontrolled Diabetic patients of Oral cancer with RIM will be excluded
- •Severe infection in the oral mucosa
- •Bleeding from lesion
- •Anemic patients below Hb- 9grams.
结局指标
主要结局
Reduced grade of- WHO oral mucositis Score
时间窗: 4 week, 8 week, 12 weeks
次要结局
- reductions in symptoms of dysphagia, bleeding, pain(15th, 30th day)
研究者
研究点 (1)
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