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临床试验/NCT02407262
NCT02407262已完成2 期

Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes

University College, London2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年5月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulrahman Koshak

Postgraduate researcher

University College, London

研究点 (2)

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