Assessing the effectiveness of Propolis and Curcumin mouthwash in the management of Radiotherapy, Chemotherapy or combined modality induced Oral Mucositis - A Randomised Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1) Reduction in WHO grading of Oral Mucositis
研究概览
简要总结
This study evaluates the effectiveness of a novel combination mouthwash containing propolis and curcumin in managing oral mucositis among postoperative oral cancer patients undergoing radiotherapy and/or chemotherapy. Oral mucositis severity will be assessed using WHO grading criteria at regular intervals to compare outcomes between those receiving the propolis-curcumin mouthwash and those on standard care. The research aims to determine whether this natural, cost-effective combination offers superior therapeutic benefits compared to conventional management, potentially providing a safer alternative for this distressed patient population.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •80 years of age. 2) Histopathologically confirmed oral squamous cell carcinoma cases who underwent surgery for oral cancer. 3) Patients undergoing conventional or intensity-modulated radiation therapy with cumulative dose of more than or equal to 50 Gy to oral cavity/oropharynx region. 4) No pre existent oral mucositis.
排除标准
- •Age less than 18 years of age 2) Previous history of Radiotherapy or chemotherapy to the head and neck region.
- •Allergic to propolis, beeswax or any other component of mouthwash.
- •Systemic severe diseases.
结局指标
主要结局
1) Reduction in WHO grading of Oral Mucositis
时间窗: Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days.
2) Reduction in VAS score
时间窗: Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days.
次要结局
- 1) severity of oral mucositis(2) duration of oral mucositis)
研究者
Dr Ruhjaan Bhagat
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES