ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02407262
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
King Abdulaziz University
Information provided by (Responsible Party):
Abdulrahman Koshak, University College, London

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


Condition or disease Intervention/treatment Phase
Asthma Dietary Supplement: Black seed oil Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment

Black seed oil capsules

1g/day for 4 weeks

Dietary Supplement: Black seed oil
Other Name: Nigella sativa oil

Placebo Comparator: Placebo

Placebo (olive oil) capsules

1g/day for 4 weeks

Other: Placebo
vegetable oil




Primary Outcome Measures :
  1. Asthma Control Test (ACT) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407262


Locations
Saudi Arabia
King Abdulaziz University Hospital
Jeddah, Saudi Arabia, 21589
Sponsors and Collaborators
University College, London
King Abdulaziz University
Investigators
Principal Investigator: Michael Heinrich, PhD University College, London

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abdulrahman Koshak, Postgraduate researcher, University College, London
ClinicalTrials.gov Identifier: NCT02407262     History of Changes
Other Study ID Numbers: 6419/002
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Abdulrahman Koshak, University College, London:
asthma
black seed
Nigella sativa
supplementation

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes