MedTrace Logo

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

NCT06560775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-20

No results posted yet for this study

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)

Interventions

COMBINATION_PRODUCT

Standard Treatment for SLE

Standard Treatment for SLE

Sponsors & Collaborators

  • University of Brawijaya

    lead OTHER

Principal Investigators

  • Wisnu Barlianto, Dr. MD · Faculty of Medicine, Universitas Brawijaya

  • Desy Wulandari, MD · Faculty of Medicine, Universitas Brawijaya

  • Tita L Sari, MD · Faculty of Medicine, Universitas Brawijaya

  • Rafika R Rachmaningrum, MD · Faculty of Medicine, Universitas Brawijaya

  • Rayi I Asasain, MD · Faculty of Medicine, Universitas Brawijaya

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2022-08-03
Completion
2023-01-03

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06560775 on ClinicalTrials.gov