An Open Label, Comparative, Three-Arm, Randomized, Parallel 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
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical assessment of Mucositis as per the World Health Organisation grading
研究概览
简要总结
The study is an open label comparative three-arm randomized parallel clinical study in which 2 variants of Turmeric Oral Rinse will be compared with normal saline for the efficacy and safety in patients during cancer chemotherapy and radiotherapy. Forty five ssubjects who fulfil the inclusion criteria will be selected. They will be randomised to one of the three groups namely Turmeric oral rinse variant 1 (Turmeric oral rinse with xanthine gum), Turmeric oral rinse Variant 2 (Turmeric oral rinse without xanthine gum) and Normal saline of 15 cases each. The subjects will be advised to use 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day. The subjects will be instructed to attend for follow up at the end of every week for 6 weeks. The study was conducted at single centre in India.
The primary outcome measures were Clinical assessments of Mucositis as per the World Health Organisation grading.
Outcome measures were measured at entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek.
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 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
Clinical assessment of Mucositis as per the World Health Organisation grading
时间窗: At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek
次要结局
- Difficulty in drinking(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek)
- Location of ulcers(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek)
- Number of ulcers(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek)
- Burning sensation(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek)
- Difficulty in chewing(At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek)
- 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 5thweek and end of 6thweek)