Status:
COMPLETED
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
Lead Sponsor:
University of Brawijaya
Conditions:
SLE (Systemic Lupus)
Eligibility:
All Genders
7-18 years
Phase:
NA
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...
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 effect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06560775
Start Date
January 3 2022
End Date
January 3 2023
Last Update
August 20 2024
Active Locations (1)
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1
Universitas Brawijaya
Malang, East Java, Indonesia, 65145