Plain English Summary
Background and study aims
Nigella sativa (NS) is a widely used medicinal plant throughout the world and is thought to have numerous health benefits including antioxidant, antimicrobial, anticancer and immune system effects. This study is designed to assess the effects of NS on the immune systems of healthy university students.
Who can participate?
Healthy university students
What does the study involve?
Participants are randomly assigned to take NS supplements (0.5, 1.0 or 2.0 g) or charcoal pills for 4 weeks. At the start and end of the study, participants have several routine clinical tests.
What are the possible benefits and risks of participating?
NS is expected to enhance the immune system in the participants with no side effects.
Where is the study run from?
Imam Abdulrahman bin Faisal University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
January 2020 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Abdullah Bamosa
Effect of nigella sativa on immunity in young healthy Saudi volunteers
Nigella sativa will enhance immunity in humans
Approved 29/01/2020 Institutional review board of Imam Abdulrahman bin Faisal University (Dammam, 31451, Saudi Arabia; +966 (0)558808829; firstname.lastname@example.org), ref: rRB -2020-UGS-01-032
Single-centre randomized double-blind placebo-controlled clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Immunity of healthy individuals
The study will be conducted on healthy male students studying in IAU and blood sampling will be carried out in the main campus university clinic. Students will take the intervention for 1 month and will be divided into four groups; three will take different doses of black seed and the fourth will serve as a control. A total of 120 participants will be enrolled in the study, 30 participants will be randomly allocated to each group. Randomization will be achieved through a computerized table generated by the appropriate program. The first group is the control group – placebo - and they will be given 162 mg of an activated charcoal oral capsule, the second group will receive one capsule of 500 mg NS, the third group will receive two capsules of NS, and the fourth group will take four capsules.
Primary outcome measure
Measured at baseline and 4 weeks:
1. Cytokines (IL-1, IL-4, IL-6, IL-10 and TNF) measured using ELISA
2. Immunoglobulins (IgG, IgM) measured using ELISA
3. Cellular immunity (CD4 & CD8) measured using flow cytometry
Secondary outcome measures
Measured at baseline and 4 weeks:
1. Blood pressure measured using sphygmomanometer
2. Heart rate measured by the researcher
3. Liver function test measured using Alinity ci & hq machines (Abbot, USA)
4. Complete blood count measured using Alinity ci & hq machines (Abbot, USA)
5. Renal function test measured using Alinity ci & hq machines (Abbot, USA)
6. General health measured using a questionnaire
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Healthy male IAU students
2. Age between 18 - 25 years
3. BMI 18.5 - 29.9 kg/m²
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Students with any acute or chronic illness (unless acute illness occurred during the study)
2. Students with abnormalities in the basic laboratory investigations
3. Participants with less than 90% compliance
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Imam Abdularahman bin Faisal University
Primary health care center
Imam Abdulrahman bin Faisal University
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. All data including basic participant information, primary and secondary outcomes and analysed data will be available for 2 years after the study endpoint. data may be sent by email upon request from authorised body with no personal participant information.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)