Nigelle 5 Study Project/ Prevention of Influenza Syndroms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- SarsCOV2 Infection
Study Overview
Brief Summary
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)
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients with an age> 40 years
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Nigella (Drug)
Outcomes
Primary Outcomes
SarsCOV2 Infection
Time Frame: one month
Respiratory infection
Secondary Outcomes
- Contamination(one month)
Investigators
Riadh Boukef
PROFESSOR
Hôpital Universitaire Sahloul