Clinical And Immunohistochemical Evaluation Of The Cancer Chemopreventive Effect Of Thymoquinone Compared To A Placebo On Oral Potentially Malignant Lesions Among An Egyptian Population : A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- clinical response
研究概览
简要总结
The present randomized, controlled, parallel-grouped trial includes 48 patients (aged 18 to 75 years) suffering from oral potential premalignant lesions. Patients will be randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
详细描述
The present randomized, controlled, parallel-grouped trial included 48 patients (aged 18 to 75 years) suffering from oral potentially premalignant lesions. Patients were randomly assigned into 3 equal groups: Group A: Nigella Sativa buccal tablets group 10mg Group B: Nigella Sativa buccal tablets 5 mg Group C:Control group (placebo)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patients with age range 18-75 years.
- •Patients with any known potentially malignant lesion confirmed histologically and clinically.
排除标准
- •Patients with systemic illness.
- •Patients received previous treatment for the condition.
- •Current malignancy.
- •Pregnant or lactating women.
- •Hypersensitivity to the intervention.
研究组 & 干预措施
Group A
patients with oral premalignant lesions will receive Nigella sativa buccal tablets 10mg for 3 months.
干预措施: Nigella sativa buccal tablets 10mg (Drug)
Group B
patients with oral premalignant lesions will receive Nigella sativa buccal tablets 5mg for 3 months.
干预措施: Nigella sativa buccal tablets 5mg (Drug)
Group 3
patients with oral premalignant lesions will receive placebo buccal tablets for 3 months.
干预措施: Placebo buccal tablets (Drug)
结局指标
主要结局
clinical response
时间窗: 3 months
dimension of the lesion
次要结局
- Molecular evidence of malignant transformation(3 months)
研究者
Ghada Nabil
Assistant lecturer
Cairo University