Clinical trial NCT06560775: Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
Official title: Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SLE (Systemic Lupus)
Keywords: Immunomodulator
T lymphocyte
Inflammatory cytokine
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
timeFrame: up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Malang
country: Indonesia
facility: Universitas Brawijaya
state: East Java
Study officials:
affiliation: Faculty of Medicine, Universitas Brawijaya
name: Wisnu Barlianto, Dr. MD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Universitas Brawijaya
name: Desy Wulandari, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Universitas Brawijaya
name: Tita L Sari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Universitas Brawijaya
name: Rafika R Rachmaningrum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Universitas Brawijaya
name: Rayi I Asasain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.