Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients

NCT06560775 | Completed

• 1 other identifier: SLE NS CBA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

SLE (Systemic Lupus)

Keywords

Immunomodulator; T lymphocyte; Inflammatory cytokine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Combination Product: Standard Treatment for SLE

Placebo group

PLACEBO COMPARATOR

Placebo capsules identical appearance contain 1 gram starch

Combination Product: Standard Treatment for SLE

Interventions

Standard Treatment for SLE COMBINATION_PRODUCT

Standard Treatment for SLE

NSO group; Placebo group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Brawijaya: lead

Study Sites (1)

Universitas Brawijaya

Malang, East Java, 65145, Indonesia

Location

Related Publications (6)

• 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.

  PMID: 37507880 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.

  PMID: 32993150 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.

  PMID: 31450670 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.

  PMID: 35450390 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.

  PMID: 27100726 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.

  PMID: 27247920 RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Wisnu Barlianto, Sp. A (K), Msi. med

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 19, 2024
• Study Start: January 3, 2022
• Primary Completion: August 3, 2022
• Study Completion: January 3, 2023
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)