Trial no.:	PACTR202007611764617	Date of Registration:	07/07/2020
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Lagos COVID-19 Black Seed Oil Trial (LACBSOT)

Official scientific title

An Open-label Clinical Trial of Anti-viral Efficacy and Immune-boosting Effects of Oral Treatment with Black Seed Oil in Patients with Corona Virus Disease (COVID-19)

Brief summary describing the background and objectives of the trial

Recently, the usage of phyto-medicine has been amplified dramatically for numerous ailments because of not only their easy accessibility and low cost but also the belief that natural remedies have fewer harmful effects as compared to synthetic medicines. Among several medicinal plants, Nigella sativa L. (Ranunculaceae) has been considered one of the most treasured nutrient-rich herb in history around the world. Nigella sativa extract decreased viral load when added to CoV infected cells (Ulasli et al., 2014). The objectives of the study include to determine the efficacy of the Black seed oil in the clearance of viral load in patients, determine the effects of the oil administration on the disease progression and/or improvement and the effects of the oil administration on some laboratory parameters.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Infections and Infestations

Sub-Disease(s) or condition(s) being studied

COVID-19

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

01/09/2020

Actual trial start date

Anticipated date of last follow up

23/10/2020

Actual Last follow-up date

Anticipated target sample size (number of participants)

80

Actual target sample size (number of participants)

Recruitment status

Not yet recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	Simple randomization using a randomization table from a statistics book	Numbered containers	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Black seed oil	Twice daily	14 days	Clear liquid	40
Control Group	LopinavirRitonavir	2 tablets twice daily	14 days	yellow, coated tablets	40	Historical

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Individuals who have been tested and confirmed to be positive Stable, not on ventilator Not having any underlining ailment males or females above 18 years.	Individuals already tested negative Known allergy to black seed oil, Those that have had treatment with any drugs or any other medicine in the last 2 weeks, Those who refused to give informed consent, Those with hypertension, pregnancy, breastfeeding, diabetes, asthma, hepatitis, or any other ailments Those participating in other studies at the Centre.	80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	80 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

26/06/2020

LUTH Health Research Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
Idi-Araba	Lagos	23401	Nigeria

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	1. Viral load at 15 day. 2. Length of stay in the hospital	15 days
Secondary Outcome	The level of inflammatory factors IL-1, IL-2, IL-6, IL-7, IL-10, granulocyte colony-stimulating factor (GCSF), interferon-gamma-induced protein (IP-10) and monocyte chemoattractant protein-1 (MCP-1)	Day 15

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Mainland Hospital Yaba	1, Mainland Hospital Drive	Yaba Lagos		Nigeria

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Lagos State Ministry of Health	State Secretariat	Alausa Ikeja		Nigeria

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Lagos State Government	State Secretariat	Alausa Ikeja		Nigeria	Government

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Ibrahim Oreagba	iaoreagba@cmul.edu.ng	+2348023519433	Idi-Araba
City	Postal code	Country	Position/Affiliation
Lagos		Nigeria	Professor of Pharmacology LUTH
Role	Name	Email	Phone	Street address
Public Enquiries	Hussein AbdurRazzaq	hussein.abdur-razzaq@lagosstate.gov.ng	+2348099355417	State Secretariat
City	Postal code	Country	Position/Affiliation
Alausa Ikeja		Nigeria	Head Health Research Unit
Role	Name	Email	Phone	Street address
Scientific Enquiries	AbdulWasiu Busari	busarial@yahoo.com	+2348033011555	1, Hospital Road, Gbagada
City	Postal code	Country	Position/Affiliation
Lagos		Nigeria	CoPrincipal Investigator

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual Participant Data that underlie the results of the study after deidentification.	Study Protocol	Beginning 9 months and ending 36 months after the publication of the study	Outside investigators upon scientific review of the merits of their proposed research plan
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry