The Use of Tulsi Extract for The Management of Oral Mucositis in Head & Neck Cancer Patients Undergoing Radiotherapy: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 主要终点
- Severity of mucositis
研究概览
简要总结
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant will use either 0.15% benzydamine (Comparator) or 4% tulsi (Intervention) four times a day and also once half an hour before each radiotherapy session.
详细描述
the primary outcome is the severity of oral mucositis will assess by Oral Mucositis Assessment Scale (OMAS) and secondary outcomes are pain will assess Numerical rating scale (NRS), Oral Assessment Guide (OAG), and Patient-Reported Oral Mucositis( PROMS scale) All outcomes will be recorded at baseline, and 8, 15 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The principal investigator and participant will be blinded as the treatment preparations will be identical in color, odor, and consistency and they will be placed in identical bottles
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having clinical signs of radiotherapy-induced OM (WHO oral mucositis grading scale: Grade II, III, and IV)
- •Patient should be able to read and/or understand and sign the consent form.
排除标准
- •Patients with HIV infections or hyperthyroidism.
- •Karnofsky performance status (KPS) less than 60%
- •Patients having an allergy to tulsi or benzydamine HCL
- •Patients who are pregnant and/or nursing.
研究组 & 干预措施
benzydamine hydrochloride
0.15% benzydamine hydrochloride
干预措施: Benzydamine Hydrochloride (Drug)
tulsi extract
4% tulsi extract as intervention
干预措施: tulsi extract (Drug)
结局指标
主要结局
Severity of mucositis
时间窗: up to 15 days
Oral Mucositis Assessment Scale (OMAS)
次要结局
- Pain and burning sensation(up to 15 days)
研究者
Karima AbdAllah Kamel
principle investigator
Cairo University