SLE (Systemic Lupus)NCT06560775
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
A study testing Standard Treatment for SLE in people with SLE (Systemic Lupus), run by University of Brawijaya at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student. It will also learn about the Treg, T helper cells, and cytokine of the patient. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- SLE (Systemic Lupus)
- What is being tested?
- Standard Treatment for SLE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Jan 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric SLE patients aging between 1 and 18 years old according to the 2010 ACR-EULAR criteria
- Being under treatment with prednisone, hydroxychloroquine, and mycophenolic acid
- Not receiving any biological agent or cytokine inhibitors for at least 2 months prior to the intervention
Who cannot join
- Patients with any metabolic disorders (diabetes mellitus, Cushing's syndrome, and thyroid dysfunctions), any kidney or liver diseases, chronic inflammatory diseases (including inflammatory bowel diseases),
- Patients with history of taking antioxidant or anti-inflammatory supplements 2 months prior to the interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus: A Randomized Controlled Trial
The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student. It will also learn about the Treg, T helper cells, and cytokine of the patient. The main questions it aims to answer are:
Does Nigella sativa oil lower the SLEDAI Score in pediatric patient? How does the effects of Nigella sativa oil on Treg cells, T helper cells, and cytokine in pediatric patient? Researchers will compare Nigella sativa oil group to a placebo group (a look-alike substance that contains no drug) to see if Nigella sativa oil works to treat SLE in pediatric patients.
Read more
Participants will:
Visit the clinic once in the beginning for pre treatment checkups. Take Nigella sativa oil or a placebo every day for 8 weeks. Visit the clinic once every 4 weeks for checkups. Visit the clinic after 8 weeks for post treatment checkups.
Read the detailed description
SLE in paediatric patients requires long-term treatment with several side effects. Nigella sativa is known to have immunomodulatory effects. Our study aimed to investigate the immune-modulatory effects of Nigella sativa oil on T lymphocyte activity, inflammatory cytokine profile, and improvement of SLEDAI score in our patients. This was a placebo-controlled clinical trial of Nigella sativa oil administration in 32 paediatric SLE patients who were tested before and after treatment. The study subjects were randomly assigned. Patients had blood samples taken to be tested for T cell ratio, percentage of a number of cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-17, and IL-10) using flow cytometry and CBA (Cytometric Bead Array), and SLEDAI score at the beginning of the study and after treatment. They were treated with 1 gram of N. sativa oil capsules and 1 gram of placebo daily for 8 weeks.
- Conditions
- SLE (Systemic Lupus)
- Being tested
- Standard Treatment for SLE
- Keywords
- Immunomodulator, T lymphocyte, Inflammatory cytokine
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Treatment for SLECombination product
Standard Treatment for SLE
| Study group | Role | What they receive |
|---|---|---|
| NSO group | Experimental | NSO is 1 gram Nigella sativa oil in capsules. It was purchased from CV Rizki Abadi, Tuban East Java, Indonesia, with registration number POM TR. 183314171 Receives: Combination Product: Standard Treatment for SLE |
| Placebo group | Placebo comparator | Placebo capsules identical appearance contain 1 gram starch Receives: Combination Product: Standard Treatment for SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
T cell lymphocyte includes Th1, Th2, Th17, and Treg in pg/mL (picograms per millilitre).
Cytokine profiles includes IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10, and IL-17α in pg/mL (picograms per millilitre).
SLEDAI Score: SLE Disease Activity Index 2000 (SLEDAI-2K) in the point range between 0-105 (the higher the score the higher the disease activity). No activity (SLEDAI=0), mild activity (SLEDAI=1 to 5), moderate activity (SLEDAI=6 to 10), high activity (SLEDAI=11 to 19), and very high activity (SLEDAI≥20).
T-cell lymphocytes and cytokine profiles will be used to determine the immunomodulating effect of Nigella sativa oil on the change of disease activity through the SLEDAI Score of paediatric SLE patients.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start3 Jan 2022
- Primary completion3 Aug 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brawijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wisnu Barlianto, University of Brawijaya
- Investigators
- Wisnu Barlianto, Dr. MD, Study chair, Faculty of Medicine, Universitas BrawijayaDesy Wulandari, MD, Study director, Faculty of Medicine, Universitas BrawijayaTita L Sari, MD, Principal investigator, Faculty of Medicine, Universitas BrawijayaRafika R Rachmaningrum, MD, Principal investigator, Faculty of Medicine, Universitas BrawijayaRayi I Asasain, MD, Principal investigator, Faculty of Medicine, Universitas Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560775
- Sponsor's protocol ID
- SLE NS CBA
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciesielska-Figlon K, Wojciechowicz K, Wardowska A, Lisowska KA. The Immunomodulatory Effect of Nigella sativa. Antioxidants (Basel). 2023 Jun 24;12(7):1340. doi: 10.3390/antiox12071340.
PubMed 37507880Pop RM, Sabin O, Suciu S, Vesa SC, Socaci SA, Chedea VS, Bocsan IC, Buzoianu AD. Nigella Sativa's Anti-Inflammatory and Antioxidative Effects in Experimental Inflammation. Antioxidants (Basel). 2020 Sep 26;9(10):921. doi: 10.3390/antiox9100921.
PubMed 32993150Nasuti C, Fedeli D, Bordoni L, Piangerelli M, Servili M, Selvaggini R, Gabbianelli R. Anti-Inflammatory, Anti-Arthritic and Anti-Nociceptive Activities of Nigella sativa Oil in a Rat Model of Arthritis. Antioxidants (Basel). 2019 Aug 25;8(9):342. doi: 10.3390/antiox8090342.
PubMed 31450670Hikmah Z, Endaryanto A, Ugrasena IDG, Rahaju AS, Arifin S. Nigella sativa L. as immunomodulator and preventive effect on renal tissue damage of lupus mice induced by pristane. Heliyon. 2022 Apr 6;8(4):e09242. doi: 10.1016/j.heliyon.2022.e09242. eCollection 2022 Apr.
PubMed 35450390Kheirouri S, Hadi V, Alizadeh M. Immunomodulatory Effect of Nigella sativa Oil on T Lymphocytes in Patients with Rheumatoid Arthritis. Immunol Invest. 2016 May;45(4):271-83. doi: 10.3109/08820139.2016.1153649. Epub 2016 Apr 21.
PubMed 27100726Hadi V, Kheirouri S, Alizadeh M, Khabbazi A, Hosseini H. Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial. Avicenna J Phytomed. 2016 Jan-Feb;6(1):34-43.
PubMed 27247920
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06560775
- Acronym / sponsor ID
- SLE NS CBA
- Conditions
- SLE (Systemic Lupus)
- Keywords
- Immunomodulator, T lymphocyte, Inflammatory cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BrawijayaUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student. It will also learn about the Treg, T helper cells, and cytokine of the patient. The main questions it aims to answer are:
Does Nigella sativa oil lower the SLEDAI Score in pediatric patient? How does the effects of Nigella sativa oil on Treg cells, T helper cells, and cytokine in pediatric patient? Researchers will compare Nigella sativa oil group to a placebo group (a look-alike substance that contains no drug) to see if Nigella sativa oil works to treat SLE in pediatric patients.
Participants will:
Visit the clinic once in the beginning for pre treatment checkups. Take Nigella sativa oil or a placebo every day for 8 weeks. Visit the clinic once every 4 weeks for checkups. Visit the clinic after 8 weeks for post treatment checkups.
Detailed description
SLE in paediatric patients requires long-term treatment with several side effects. Nigella sativa is known to have immunomodulatory effects. Our study aimed to investigate the immune-modulatory effects of Nigella sativa oil on T lymphocyte activity, inflammatory cytokine profile, and improvement of SLEDAI score in our patients. This was a placebo-controlled clinical trial of Nigella sativa oil administration in 32 paediatric SLE patients who were tested before and after treatment. The study subjects were randomly assigned. Patients had blood samples taken to be tested for T cell ratio, percentage of a number of cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-17, and IL-10) using flow cytometry and CBA (Cytometric Bead Array), and SLEDAI score at the beginning of the study and after treatment. They were treated with 1 gram of N. sativa oil capsules and 1 gram of placebo daily for 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSO group | Experimental | Combination Product: Standard Treatment for SLENSO is 1 gram Nigella sativa oil in capsules. It was purchased from CV Rizki Abadi, Tuban East Java, Indonesia, with registration number POM TR. 183314171 |
| Placebo group | Placebo comparator | Combination Product: Standard Treatment for SLEPlacebo capsules identical appearance contain 1 gram starch |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric SLE patients aging between 1 and 18 years old according to the 2010 ACR-EULAR criteria
- Being under treatment with prednisone, hydroxychloroquine, and mycophenolic acid
- Not receiving any biological agent or cytokine inhibitors for at least 2 months prior to the intervention
Key exclusion criteria (2 listed)
- Patients with any metabolic disorders (diabetes mellitus, Cushing's syndrome, and thyroid dysfunctions), any kidney or liver diseases, chronic inflammatory diseases (including inflammatory bowel diseases),
- Patients with history of taking antioxidant or anti-inflammatory supplements 2 months prior to the interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Treatment for SLEStandard Treatment for SLE | Combination product | NSO group, Placebo group |
Primary outcome
T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
Time frame: up to 4 months
T cell lymphocyte includes Th1, Th2, Th17, and Treg in pg/mL (picograms per millilitre). Cytokine profiles includes IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10, and IL-17α in pg/mL (picograms per millilitre). SLEDAI Score: SLE Disease Activity Index 2000 (SLEDAI-2K) in the point range between 0-105 (the higher the score the higher the disease activity). No activity (SLEDAI=0), mild activity (SLEDAI=1 to 5), moderate activity (SLEDAI=6 to 10), high activity (SLEDAI=11 to 19), and very high activity (SLEDAI≥20). T-cell lymphocytes and cytokine profiles will be used to determine the immunomodulating effect of Nigella sativa oil on the change of disease activity through the SLEDAI Score of paediatric SLE patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Results publication: PubMed 37507880Ciesielska-Figlon K, Wojciechowicz K, Wardowska A, Lisowska KA. The Immunomodulatory Effect of Nigella sativa. Antioxidants (Basel). 2023 Jun 24;12(7):1340. doi: 10.3390/antiox12071340.
- Results publication: PubMed 32993150Pop RM, Sabin O, Suciu S, Vesa SC, Socaci SA, Chedea VS, Bocsan IC, Buzoianu AD. Nigella Sativa's Anti-Inflammatory and Antioxidative Effects in Experimental Inflammation. Antioxidants (Basel). 2020 Sep 26;9(10):921. doi: 10.3390/antiox9100921.
- Results publication: PubMed 31450670Nasuti C, Fedeli D, Bordoni L, Piangerelli M, Servili M, Selvaggini R, Gabbianelli R. Anti-Inflammatory, Anti-Arthritic and Anti-Nociceptive Activities of Nigella sativa Oil in a Rat Model of Arthritis. Antioxidants (Basel). 2019 Aug 25;8(9):342. doi: 10.3390/antiox8090342.
- Results publication: PubMed 35450390Hikmah Z, Endaryanto A, Ugrasena IDG, Rahaju AS, Arifin S. Nigella sativa L. as immunomodulator and preventive effect on renal tissue damage of lupus mice induced by pristane. Heliyon. 2022 Apr 6;8(4):e09242. doi: 10.1016/j.heliyon.2022.e09242. eCollection 2022 Apr.
- Results publication: PubMed 27100726Kheirouri S, Hadi V, Alizadeh M. Immunomodulatory Effect of Nigella sativa Oil on T Lymphocytes in Patients with Rheumatoid Arthritis. Immunol Invest. 2016 May;45(4):271-83. doi: 10.3109/08820139.2016.1153649. Epub 2016 Apr 21.
- Results publication: PubMed 27247920Hadi V, Kheirouri S, Alizadeh M, Khabbazi A, Hosseini H. Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial. Avicenna J Phytomed. 2016 Jan-Feb;6(1):34-43.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wisnu Barlianto, Dr. MD study chair
Faculty of Medicine, Universitas Brawijaya
Desy Wulandari, MD study director
Faculty of Medicine, Universitas Brawijaya
Tita L Sari, MD principal investigator
Faculty of Medicine, Universitas Brawijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment for SLE in people with SLE (Systemic Lupus), run by University of Brawijaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T cell lymphocyte and cytokine profiles, as well as SLEDAI Score (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560775, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.