Condition category
Not Applicable
Date applied
29/10/2020
Date assigned
16/11/2020
Last edited
16/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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
bamosa@iau.edu.sa

Trial website

Contact information

Type

Scientific

Primary contact

Prof Abdullah Bamosa

ORCID ID

http://orcid.org/0000-0001-5941-4353

Contact details

Imam Abdulrahman bin Faisal University
Dammam
31451
Saudi Arabia
+966 (0)505853161
bamosa@iau.edu.sa

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

032

Study information

Scientific title

Effect of nigella sativa on immunity in young healthy Saudi volunteers

Acronym

Study hypothesis

Nigella sativa will enhance immunity in humans

Ethics approval

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

Study design

Single-centre randomized double-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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

29/01/2020

Overall trial end date

30/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy male IAU students
2. Age between 18 - 25 years
3. BMI 18.5 - 29.9 kg/m²

Participant type

Healthy volunteer

Age group

Adult

Gender

Male

Target number of participants

120

Total final enrolment

64

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

01/02/2020

Recruitment end date

01/04/2020

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Imam Abdularahman bin Faisal University
Primary health care center
Dammam
31451
Saudi Arabia

Sponsor information

Organisation

Imam Abdularahman bin Faisal University

Sponsor details

King Faisal Rd
Dammam
31451
Saudi Arabia
+966 (0)3333400
dsr@iau.edu.sa

Sponsor type

Government

Website

http://www.iau.edu.sa

Funders

Funder type

University/education

Funder name

Imam Abdulrahman bin Faisal University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Under preparation

Publication citations

Additional files

Editorial Notes

13/11/2020: Trial’s existence confirmed by Imam Abdulrahman bin Faisal University.