Nigelle 5 Study Project/ Prevention of Influenza Syndroms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- SarsCOV2 Infection
研究概览
简要总结
This study will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
详细描述
This study will focus on the evaluation of the natural product Nigella Sativa in the fractalized form. "Lactose Nigelle 5" from the Tunisian company Fractal Tun, in terms of possible contribution to the prevention of influenza-like illnesses, in particular COVID-19
It will be carried out by more than 30 liberal Tunisian doctors, who will submit according to the inclusion / exclusion criteria of people who will receive (free of charge) a capsule of the Nig5 product sublingually, each day. Against a control group which will be followed with the same protocol as the first but which will not receive the product. Randomization (even days: nigella group, odd days: control group)
The monitoring and evaluation will last for 3 weeks with taking the product Nig5, followed by a week without taking the product. That is 4 weeks in all.
More than 30 physicians volunteered to participate in this study without remuneration and without consultation fees for the candidates.
This study will be supervised by Professor Riadh Boukef, head of emergency services at Sahloul University Hospital, who will collect all the data afterwards in order to submit them to the statistical tools in force.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with an age> 40 years
排除标准
- •Being positive for COVID or having contracted it previously
- •Positive for COVID between D1 and D5 of the study, meaning that there was infection before inclusion.
- •Immunocompromised (HIV, other ...)
- •Under chemotherapy
- •On immunosuppressants
- •Pregnant women
研究组 & 干预措施
Nigelle Group
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
干预措施: Nigella (Drug)
结局指标
主要结局
SarsCOV2 Infection
时间窗: one month
Respiratory infection
次要结局
- Contamination(one month)
研究者
Riadh Boukef
PROFESSOR
Hôpital Universitaire Sahloul
