Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
研究概览
简要总结
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.
详细描述
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 effects of Nigella sativa oil on T lymphocyte activity, inflammatory cytokine profile, and improvement of SLEDAI score in our patients. This was a placebo-controlled clinical trial of Nigella sativa oil administration in 32 paediatric SLE patients who were tested before and after treatment. The study subjects were randomly assigned. Patients had blood samples taken to be tested for T cell ratio, percentage of a number of cytokines (IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-17, and IL-10) using flow cytometry and CBA (Cytometric Bead Array), and SLEDAI score at the beginning of the study and after treatment. They were treated with 1 gram of N. sativa oil capsules and 1 gram of placebo daily for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
时间窗: up to 4 months
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.
次要结局
未报告次要终点
研究者
Wisnu Barlianto
Dr. dr. Wisnu Barlianto, Sp. A (K), Msi. med
University of Brawijaya