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OpenTrials
Completed

NCT Number: NCT02407262

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

King Abdulaziz University Hospital

Jeddah, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Black seed oil

Dietary Supplement

Other names: Nigella sativa oil

Placebo

Other

vegetable oil

Primary outcomes

  1. Asthma Control Test (ACT)

    Time frame: 4 weeks

Secondary outcomes

  1. Serum inflammatory mediators

    Time frame: 4 weeks

    IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g

  2. Total IgE

    Time frame: 4 weeks

  3. Complete blood count (CBC)

    Time frame: 4 weeks

    Mainly blood eosinophils

  4. Pulmonary function test (predicted FEV1%)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • King Abdulaziz University

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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