An interventional study of Nigella in COVID-19 Acute Respiratory Distress Syndrome, sponsored by Hôpital Universitaire Sahloul. Completed at 1 site in Tunisia. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by Hôpital Universitaire Sahloul · Not applicable, Interventional, and Prevention
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)
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 500 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hôpital Universitaire Sahloul is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
Drug: Nigella
Follow-up should be done weekly for 1 month.
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
SarsCOV2 Infection
Respiratory infection
Time frame: one month
Contamination
contamination of the entourage in the event of respiratory infection by COVID19
Time frame: one month
Plan to share: Yes — Data Statistical analysis
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Hôpital Universitaire Sahloul