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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02407262
Enrollment
80
Registered
2015-04-02
Start date
2015-05-31
Completion date
2015-12-31
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, black seed, Nigella sativa, supplementation

Brief summary

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

Interventions

DIETARY_SUPPLEMENTBlack seed oil
OTHERPlacebo

vegetable oil

Sponsors

King Abdulaziz University
CollaboratorOTHER
University College, London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Asthma Control Test (ACT)4 weeks

Secondary

MeasureTime frameDescription
Serum inflammatory mediators4 weeksIL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
Total IgE4 weeks
Complete blood count (CBC)4 weeksMainly blood eosinophils
Pulmonary function test (predicted FEV1%)4 weeks

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026