An Open Label, Clinical Study to Evaluate the Efficacy and Safety of Turmeric Oral Rinse in Oral Mucositis During Cancer Chemotherapy and Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mucositis Assessment:
研究概览
简要总结
The study is an open label Clinical Study to Evaluate the Efficacy and Safety of Turmeric Oral Rinse in Oral Mucositis during Cancer Chemotherapy and Radiotherapy. Forty subjects who fulfil the inclusion criteria will be selected. The subjects will be advised to use 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day from day 1 of standard care. The subjects will be instructed to attend for follow up at the end of every week for 6 weeks. The primary outcome measures are Clinical assessments of Mucositis as per the World Health Organisation grading.
Outcome measures will be measured at entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week.
Clinical symptoms like sore throat, number of ulcer, burning sensation, pain, difficulty in chewing, difficulty in drinking and mucositis grading along with PROMS (patient reported outcome measures) were evaluated at each interval. Significant positive outcome was reported both subjectively and objectively with delay in the onset of symptoms and less severe manifestation of oral mucositis with an improvement in quality of life. No adverse effects reported that prompted discontinuation of study medication. Overall compliance to study medication was good.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects with confirmed histopathologically with head and neck cancer (according to TNM classification) preferably oropharyngeal scheduled to receive chemotherapy or radiotherapy as a standard care.
- •2 Subjects with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy.
- •3 Subjects aged >18 years of either the sex.
- •4 Subjects willing to give a written informed consent and follow the schedule of the study as per the protocol.
排除标准
- •1 Has participated in a similar clinical investigation in the past four weeks.
- •2 Severe uncontrolled systemic disorders, diabetes, Hypertension, or genetic and endocrinal disorders.
- •3 Has used a similar product in the past four weeks.
- •4 Subjects who refused to sign informed consent.
- •5 Pregnant and lactating women.
结局指标
主要结局
Mucositis Assessment:
时间窗: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week
Condition of the patient’s mouth is assessed at weekly intervals, as per the World Health Organisation grading of mucositis
时间窗: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week
次要结局
- Number of ulcers(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)
- Location of ulcers(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)
- Difficulty in chewing(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)
- Difficulty in drinking(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)
- Difficulty in opening the mouth(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)
- Burning sensation(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week)