Effect of black seed on immunity in young healthy Saudi volunteers
| ISRCTN | ISRCTN14150499 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14150499 |
| Secondary identifying numbers | 032 |
- 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
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
Scientific
Imam Abdulrahman bin Faisal University
Dammam
31451
Saudi Arabia
 ORCID ID |
0000-0001-5941-4353 |
|---|---|
| Phone | +966 (0)505853161 |
| bamosa@iau.edu.sa |
Study information
| Study design | Single-centre randomized double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a 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 | 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 study start date | 29/01/2020 |
| 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 number of participants | 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
Dammam
31451
Saudi Arabia
Sponsor information
Government
King Faisal Rd
Dammam
31451
Saudi Arabia
| Phone | +966 (0)3333400 |
|---|---|
| dsr@iau.edu.sa | |
| Website | http://www.iau.edu.sa |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Protocol file | 02/12/2020 | No | No | ||
| Results article | 25/11/2021 | 14/03/2022 | Yes | No | |
| Results article | 18/10/2023 | 21/12/2023 | Yes | 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.
