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NCT06560775
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
NA trial testing Standard Treatment for SLE in SLE (Systemic Lupus) in 32 participants. Completed in 3 January 2023.
3 August 2022
Quick facts
| Lead sponsor | University of Brawijaya |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 32 |
| Start date | 3 January 2022 |
| Primary completion | 3 August 2022 |
| Estimated completion | 3 January 2023 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Standard Treatment for SLE
Conditions studied
- SLE (Systemic Lupus) — all drugs for SLE (Systemic Lupus) →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06560775
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06560775 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Brawijaya
- Last refreshed: 20 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06560775.
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