Official Title
Nigelle 5 Study Project/ Prevention of Influenza Syndroms
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.

Professor Boukef will be responsible for preparing the abstract and publishing it on his
behalf in the scientific journals of his choice, naming the doctors who participated as well
as the product in question and the company that markets it in Tunisia.

27 free practice doctors participate in patient recruitment: AMICHE Sondèss BAHA Mohamed BEN
AMARA Mohamed Khalil BEN ARBIA Karima BEN AYAD Afef BEN AYED KTARI Fouzia BENTALEB Mourad
BESBES Mohamed CHTOUROU Iteb DHOUIB Manel DJAIT Mohamed DJEMAL Najla ELFIDHA Mongi FOURATI
Imen FRIH Sabria FRIKHA Fahmi GHARBI Nadia KAMMOUN Naziha KETATA Mourad MHIRI Ikram NJAH
Jamil OUARGHI Sameh REGAIEG Mourad SAKKA Samar TRABELSI Hinda ZOUARI Imen ZOUARI Nassira

Completed
COVID-19 Acute Respiratory Distress Syndrome

Drug: Nigella

The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 40 Years ~ Maximum: N/A
Countries
Tunisia
Locations

HU Sahloul, sousse, Tunisia
Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia

Riadh Boukef, professor, Principal Investigator
CHU Sahloul, Sousse, Tunisia

Hôpital Universitaire Sahloul
NCT Number
Keywords
Nigelle 5CH
Covid-19
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury