Nigelle 5 in Prevention of Influanza (NigCOV3)

Nigelle 5 Study Project/ Prevention of Influenza Syndroms

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)

Study Overview

• Status: Completed
• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Nigella

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

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Itinéraire Ceinture Cité Sahloul
    • Sousse, Itinéraire Ceinture Cité Sahloul, Tunisia, 4054
      • HU Sahloul, sousse, Tunisia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
NO_INTERVENTION: Placebo Group; Follow-up should be done weekly for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SarsCOV2 Infection	Respiratory infection	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contamination	contamination of the entourage in the event of respiratory infection by COVID19	one month

Collaborators and Investigators

• Sponsor: Hôpital Universitaire Sahloul

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2021
• Primary Completion (ACTUAL): July 31, 2021
• Study Completion (ACTUAL): August 31, 2021

Study Registration Dates

• First Submitted: July 24, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (ACTUAL): August 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Covid-19; Nigelle 5CH
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: NigCOV 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data Statistical analysis
• IPD Sharing Time Frame: The data will be available after publication
• IPD Sharing Access Criteria: all Criteria will be shared in the accepted article
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No