Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Asthma Control Questionnaire (ACQ)
研究概览
简要总结
Complementary and adjunctive therapies are increasingly being explored to enhance asthma control and reduce airway inflammation. Nigella sativa (black seed) is a medicinal plant used traditionally in multiple regions and has demonstrated anti-inflammatory, immunomodulatory, and bronchodilator effects. Its potential as an adjuvant therapy in asthma has attracted attention in both preclinical and clinical research
详细描述
We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-18 years
- •Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines
- •Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment
- •Able to perform reproducible spirometry
排除标准
- •History of severe asthma exacerbation requiring ICU admission in the past 3 months
- •Use of systemic corticosteroids within 4 weeks prior to enrollment
- •Known hypersensitivity to Nigella sativa or its components
- •Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis)
- •Significant comorbidities (e.g., cardiac, renal, or hepatic disorders)
- •Inability to comply with study procedures
研究组 & 干预措施
Standard asthma Controller Therapy Only
30 children with moderate persistent asthma receiving standard controller therapy consisting of a combined low-dose inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA), administered by metered-dose inhaler with spacer.
干预措施: Nigella sativa Oil Capsules (50 mg/kg/day) (Dietary Supplement)
Standard asthma Controller Therapy Only
30 children with moderate persistent asthma receiving standard controller therapy consisting of a combined low-dose inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA), administered by metered-dose inhaler with spacer.
干预措施: Nigella sativa Oil Capsules (100 mg/kg/day) (Dietary Supplement)
Standard Therapy + Nigella sativa (50 mg/kg/day)
30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 50 mg/kg/day as adjunct therapy.
干预措施: Nigella sativa Oil Capsules (100 mg/kg/day) (Dietary Supplement)
Standard Therapy + Nigella sativa (50 mg/kg/day)
30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 50 mg/kg/day as adjunct therapy.
干预措施: Fluticasone / Long-Acting Beta-2 Agonist Combination (Drug)
Standard Therapy + Nigella sativa (100 mg/kg/day)
30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 100 mg/kg/day as adjunct therapy.
干预措施: Nigella sativa Oil Capsules (50 mg/kg/day) (Dietary Supplement)
Standard Therapy + Nigella sativa (100 mg/kg/day)
30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 100 mg/kg/day as adjunct therapy.
干预措施: Fluticasone / Long-Acting Beta-2 Agonist Combination (Drug)
结局指标
主要结局
Asthma Control Questionnaire (ACQ)
时间窗: 12 weeks
Forced Expiratory Volume in 1 second (FEV₁)
时间窗: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Forced Vital Capacity (FVC)
时间窗: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
FEV₁/FVC ratio
时间窗: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Peak Expiratory Flow (PEF)
时间窗: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
次要结局
未报告次要终点
研究者
Rehab Zaki Elmeazawy
Associate professor of pediatrics
Tanta University