Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007611764617 Date of Approval: 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-18 Year,Adult: 19 Year-44 Year,Aged: 65+ 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