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

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ClinicalTrials.gov Identifier: NCT02407262

Recruitment Status : Completed

First Posted : April 2, 2015

Last Update Posted : May 12, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

King Abdulaziz University

Information provided by (Responsible Party):

Abdulrahman Koshak, University College, London

Study Description

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 Design

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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

MedlinePlus related topics: Asthma

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Asthma Control Test (ACT) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

Contacts and Locations

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

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Saudi Arabia
King Abdulaziz University Hospital
Jeddah, Saudi Arabia, 21589

Sponsors and Collaborators

University College, London

King Abdulaziz University

Investigators

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Principal Investigator:	Michael Heinrich, PhD	University College, London

More Information

Publications:

Al Moamary MS. Unconventional therapy use among asthma patients in a tertiary care center in Riyadh, Saudi Arabia. Ann Thorac Med. 2008 Apr;3(2):48-51. doi: 10.4103/1817-1737.39636.

Al-Moamary MS, Alhaider SA, Al-Hajjaj MS, Al-Ghobain MO, Idrees MM, Zeitouni MO, Al-Harbi AS, Al Dabbagh MM, Al-Matar H, Alorainy HS. The Saudi initiative for asthma - 2012 update: Guidelines for the diagnosis and management of asthma in adults and children. Ann Thorac Med. 2012 Oct;7(4):175-204. doi: 10.4103/1817-1737.102166.

Boskabady MH, Javan H, Sajady M, Rakhshandeh H. The possible prophylactic effect of Nigella sativa seed extract in asthmatic patients. Fundam Clin Pharmacol. 2007 Oct;21(5):559-66. doi: 10.1111/j.1472-8206.2007.00509.x. Erratum In: Fundam Clin Pharmacol. 2008 Feb;22(1):105.

Salem ML. Immunomodulatory and therapeutic properties of the Nigella sativa L. seed. Int Immunopharmacol. 2005 Dec;5(13-14):1749-70. doi: 10.1016/j.intimp.2005.06.008. Epub 2005 Jul 1.

Lebling, R., & Pepperdine, D. (2006). Natural Remedies of Arabia (p. 223). Stacey Intl.

Salama, R. (2010). Clinical and Therapeutic Trials of Nigella Sativa. TAF Preventive Medicine Bulletin, 9(5), 513-522.

Singh BB, Khorsan R, Vinjamury SP, Der-Martirosian C, Kizhakkeveettil A, Anderson TM. Herbal treatments of asthma: a systematic review. J Asthma. 2007 Nov;44(9):685-98. doi: 10.1080/02770900701247202.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koshak A, Wei L, Koshak E, Wali S, Alamoudi O, Demerdash A, Qutub M, Pushparaj PN, Heinrich M. Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Trial. Phytother Res. 2017 Mar;31(3):403-409. doi: 10.1002/ptr.5761. Epub 2017 Jan 17.

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Responsible Party:	Abdulrahman Koshak, Postgraduate researcher, University College, London
ClinicalTrials.gov Identifier:	NCT02407262
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:

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Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes

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