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临床试验/NCT04989101
NCT04989101已完成不适用

Nigelle 5 Study Project/ Prevention of Influenza Syndroms

Hôpital Universitaire Sahloul1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年6月5日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Riadh Boukef

PROFESSOR

Hôpital Universitaire Sahloul

研究点 (1)

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