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

Study Overview
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Brief Summary
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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

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

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: Black seed oil
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Black seed oil capsules 1g/day for 4 weeks | Dietary Supplement: Black seed oil<br> <br> * Other names: Nigella sativa oil;|
| Placebo Comparator: Placebo<br>Placebo (olive oil) capsules 1g/day for 4 weeks | Other: Placebo<br>* vegetable oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test (ACT) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum inflammatory mediators | IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g | 4 weeks | 
| Total IgE |  | 4 weeks | 
| Complete blood count (CBC) | Mainly blood eosinophils | 4 weeks | 
| Pulmonary function test (predicted FEV1%) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, black seed, Nigella sativa, supplementation