Nigelle 5 in Prevention of Influanza (NigCOV3)
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Nigella
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Acute Respiratory Distress Syndrome focused on measuring Nigelle 5CH, Covid-19
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
Sites / Locations
- HU Sahloul, sousse, Tunisia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Nigelle Group
Placebo Group
Arm Description
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
Follow-up should be done weekly for 1 month.
Outcomes
Primary Outcome Measures
SarsCOV2 Infection
Respiratory infection
Secondary Outcome Measures
Contamination
contamination of the entourage in the event of respiratory infection by COVID19
Full Information
NCT ID
NCT04989101
First Posted
July 24, 2021
Last Updated
January 17, 2022
Sponsor
Hôpital Universitaire Sahloul
1. Study Identification
Unique Protocol Identification Number
NCT04989101
Brief Title
Nigelle 5 in Prevention of Influanza
Acronym
NigCOV3
Official Title
Nigelle 5 Study Project/ Prevention of Influenza Syndroms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Sahloul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
Keywords
Nigelle 5CH, Covid-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nigelle Group
Arm Type
Active Comparator
Arm Description
The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
Follow-up should be done weekly for 1 month.
Intervention Type
Drug
Intervention Name(s)
Nigella
Intervention Description
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 Outcome Measure Information:
Title
SarsCOV2 Infection
Description
Respiratory infection
Time Frame
one month
Secondary Outcome Measure Information:
Title
Contamination
Description
contamination of the entourage in the event of respiratory infection by COVID19
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riadh Boukef, professor
Organizational Affiliation
CHU Sahloul, Sousse, Tunisia
Official's Role
Principal Investigator
Facility Information:
Facility Name
HU Sahloul, sousse, Tunisia
City
Sousse
State/Province
Itinéraire Ceinture Cité Sahloul
ZIP/Postal Code
4054
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Nigelle 5 in Prevention of Influanza
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