Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product that has a wide range of medical claims (including asthma) that originate from different historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept those traditional medical claims of medicinal plants without valid scientific experiments. Thus, randomized clinical trials is important to rational the uses of herbal products.
Asthma is a common chronic disorder of the airways, characterized by variable reversible and recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014 considered Asthma as an epidemic disease probably affecting about 334 million people worldwide and becoming a global health priority.
This project investigates the use of herbal products to enhance asthma control in Saudi Arabia. In this context, Black Seed is one of the common herbal products used traditionally for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10% of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed in Asthma and its underlying causes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male/female (age 18-65 years),
- •asthmatic patient with Asthma Control Test (ACT) score <25
- •No severe asthma exacerbation in the last 4 weeks
- •Able to obtain consent
排除标准
- •Patients with serious co-morbid conditions such as; cancer, renal, hepatic, cardio-vascular, gastrointestinal diseases, mental health conditions and respiratory disorder such as TB and COPD.
- •Smoking history
- •Pregnant women
- •Currently taking any form of Black seed.
- •Known history of hypersensitivity to Black seed.
- •Taking medications that may interact with black seed supplement: Anticoagulant/Antiplatelet, CNS depressants, and Immunosuppressant drugs
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 4 weeks
次要结局
- Total IgE(4 weeks)
- Pulmonary function test (predicted FEV1%)(4 weeks)
- Serum inflammatory mediators(4 weeks)
- Complete blood count (CBC)(4 weeks)
研究者
Abdulrahman Koshak
Postgraduate researcher
University College, London
