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Completed

NCT Number: NCT04989101

Nigelle 5 in Prevention of Influanza

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)

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HU Sahloul, sousse, Tunisia

Sousse, Itinéraire Ceinture Cité Sahloul, 4054, Tunisia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nigella

Drug

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

Primary outcomes

  1. SarsCOV2 Infection

    Time frame: one month

    Respiratory infection

Secondary outcomes

  1. Contamination

    Time frame: one month

    contamination of the entourage in the event of respiratory infection by COVID19

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Sahloul

Other

Registry information

Official study title

Nigelle 5 Study Project/ Prevention of Influenza Syndroms

Acronym: NigCOV3

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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