Effect of black seed on immunity in young healthy Saudi volunteers

ISRCTN	ISRCTN14150499
DOI	https://doi.org/10.1186/ISRCTN14150499
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	032
Sponsor	Imam Abdularahman bin Faisal University
Funder	Imam Abdulrahman bin Faisal University

Submission date: 29/10/2020
Registration date: 16/11/2020
Last edited: 21/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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
bamosa@iau.edu.sa

Contact information

Prof Abdullah Bamosa
Scientific

Imam Abdulrahman bin Faisal University
Dammam
31451
Saudi Arabia

ORCID ID	0000-0001-5941-4353
Phone	+966 (0)505853161
Email	bamosa@iau.edu.sa

Study information

Primary study design	Interventional
Study design	Single-centre randomized double-blind placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effect of nigella sativa on immunity in young healthy Saudi volunteers
Study objectives	Nigella sativa will enhance immunity in humans
Ethics approval(s)	Approved 29/01/2020 Institutional review board of Imam Abdulrahman bin Faisal University (Dammam, 31451, Saudi Arabia; +966 (0)558808829; dsr@iau.edu.sa), ref: rRB -2020-UGS-01-032
Health condition(s) or problem(s) studied	Immunity of healthy individuals
Intervention	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.
Intervention type	Supplement
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/12/2020

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	25 Years
Sex	Male
Target sample size at registration	120
Total final enrolment	64
Key inclusion criteria	1. Healthy male IAU students 2. Age between 18 - 25 years 3. BMI 18.5 - 29.9 kg/m²
Key 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
Date of first enrolment	01/02/2020
Date of final enrolment	01/04/2020

Locations

Countries of recruitment

Saudi Arabia

Study participating centre

Imam Abdularahman bin Faisal University

Primary health care center
Dammam
31451
Saudi Arabia

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/11/2021	14/03/2022	Yes	No
Results article		18/10/2023	21/12/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file			02/12/2020	No	No

Additional files

ISRCTN14150499_PROTOCOL.pdf: Uploaded 02/12/2020

Editorial Notes

21/12/2023: Publication reference added.
14/03/2022: Publication reference added.
02/12/2020: The intention to publish date was changed from 01/12/2020 to 01/01/2021.
02/12/2020: Uploaded protocol (not peer reviewed).
13/11/2020: Trial’s existence confirmed by Imam Abdulrahman bin Faisal University.