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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo group | Placebo Comparator | Placebo capsules identical appearance contain 1 gram starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment for SLE | Combination Product | Standard Treatment for SLE |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wisnu Barlianto, Dr. MD | Faculty of Medicine, Universitas Brawijaya | Study Chair |
| Desy Wulandari, MD | Faculty of Medicine, Universitas Brawijaya | Study Director |
| Tita L Sari, MD | Faculty of Medicine, Universitas Brawijaya | Principal Investigator |
| Rafika R Rachmaningrum, MD | Faculty of Medicine, Universitas Brawijaya | Principal Investigator |
| Rayi I Asasain, MD | Faculty of Medicine, Universitas Brawijaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Brawijaya | Malang | East Java | 65145 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37507880 | Result | 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. | |
| 32993150 | Result | Pop 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2024 | Aug 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2024 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 31450670 | Result | Nasuti 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. |
| 35450390 | Result | Hikmah 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. |
| 27100726 | Result | Kheirouri 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. |
| 27247920 | Result | Hadi 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. |