COMPARATIVE ASSESSMENT OF POMEGRANATE AND GRAPEFRUIT SEED EXTRACT WITH POVIDONE IODINE IN MANAGEMENT OF RADIATION INDUCED ORAL MUCOSITIS.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome of the Study: -
研究概览
简要总结
The present study aims to compare and evaluate the efficacy of pomegranate and grapefruit seed extracts with povidone iodine mouthwash for prophylaxis and treatment of RIOM. Two groups of 30 patients each, who are scheduled to receive Radiotherapy involving oral cavity, shall be randomly assigned to either treatment or control groups.
The study design involves administering the designated mouthwash to the respective groups and monitoring the patients health of oral mucosa over a specified period. Key parameters for evaluation include inflammation levels and severity of mucositis (if any) assessed by OMAS, symptoms of burning sensation with VAS and ease of swallowing, during radiation therapy.
By comparing the outcomes between the two groups, the study aims to provide insights into the potential benefits of using pomegranate and grapefruit seed extracts as mouthwash for prophylaxis or treatment of RIOM.
Such findings could contribute to enhancing RIOM treatment protocols and optimizing patient outcome during radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to participate in the study and sign the written consent.
- •Patients who are diagnosed with histopathologically proven malignancy of oral cavity.
- •Patients who have been scheduled for postoperative external beam radiation therapy.
- •The patients who are receiving radiation therapy for the first time.
- •The patients who are scheduled to receive a total radiation dose ranging between 60 and 70 Gy. The total duration of external beam radiation therapy should be not less than 6 weeks period delivered at 30 fractions.
- •Patients who are willing to come for weekly evaluation.
排除标准
- •Patients not willing to participate in the study.
- •Patients with prior history of radiotherapy for any malignancy.
- •Patients who have received prior chemotherapy for the management of any past or present malignancy.
- •Patients diagnosed with Oral Submucous Fibrosis.
- •Patients having any systemic illnesses and taking medications for the same especially diabetes mellitus, hypertension, renal disorders, hepatic disorders, haematological disorders, immunological disorders, gastrointestinal disorders, etc.
- •Patients experiencing xerostomia and oral sores due to ill fitting dentures.
- •Patients taking analgesics for other medical conditions.
结局指标
主要结局
Primary outcome of the Study: -
时间窗: Six weeks
The result of the study will help to determine whether extracts of pomegranate and grapefruit seed can be considered as effective
时间窗: Six weeks
prophylactic and preventive measure for radiation induced oral mucositis.
时间窗: Six weeks
次要结局
- It will also help reduce the medications which are currently being used for(palliative care among patients with radiation induced oral mucositis.)
研究者
Dr ZEENA GUPTA
GOVERNMENT DENTAL COLLEGE, RAIPUR