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NCT06560775

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

Completed NA Last updated 20 August 2024
What this trial tests

NA trial testing Standard Treatment for SLE in SLE (Systemic Lupus) in 32 participants. Completed in 3 January 2023.

Timeline
3 January 2022
Primary endpoint
3 August 2022
3 January 2023

Quick facts

Lead sponsorUniversity of Brawijaya
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment32
Start date3 January 2022
Primary completion3 August 2022
Estimated completion3 January 2023
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

University of Brawijaya

Who can join

Adults 7 to 18, any sex, with SLE (Systemic Lupus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of <i>Nigella sativa</i> on disease activity, T lymphocytes and inflammatory cytokine profiles in pediatric systemic lupus erythematosus: A randomized controlled trial.
    Barlianto W, Wulandari D, Sari TL, Rachmaningrum RR, et al · · 2024 · PMID 39816053 · DOI 10.52225/narra.v4i3.1063

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Other recruiting trials for SLE (Systemic Lupus)

Currently open trials in the same condition.

Other University of Brawijaya trials

Trials by the same sponsor.

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Data sources for this page

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