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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02407262
• Other study ID #: 6419/002
• Status: Recruiting
• Phase: Phase 2
• First received: March 30, 2015
• Last updated: November 30, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University College, London
• Contact: Abdulrahman Koshak, PharmD
• Phone: +966543292333
• Email: abdulrahman.koshak.12[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In the Arabic and Islamic culture, Black Seed (Nigella sativa) is a well-known food supplement and herbal product. Traditionally, it is used as a food spice and it has wide range of medical claims 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. Yet, it is important to rational the uses of these herbal product based on clinical evidence.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult male/female (age 18-65 years),

• Partial and Uncontrolled asthmatic patient based on GINA guidelines (ACT score 5-20)

• 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, Antidiabetic, Antihypertensive, CNS depressants, and Immunosuppressant drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Dietary Supplement:
• Black seed oil

Other:
• Placebo
vegetable oil

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University Hospital	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Erratum in: Fundam Clin Pharmacol. 2008 Feb;22(1):105. — View Citation

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.

Salem ML. Immunomodulatory and therapeutic properties of the Nigella sativa L. seed. Int Immunopharmacol. 2005 Dec;5(13-14):1749-70. Epub 2005 Jul 1. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test (ACT)		4 weeks	No
Primary	Lung function test (FEV1)		4 weeks	No
Secondary	Serum inflammatory biomarkers	IL4, IL5, IL8, IL6, IL9, IL10, IL13, TNFa, TGFa, TGFb, IFN-g, INF-a, INF-b	4 weeks	No
Secondary	Serum ECP (Eosinophil Cationic Protein)		4 weeks	No
Secondary	Total Immunoglobulins levels	IgG, IgA, IgM, IgE	4 weeks	No
Secondary	Allergen-specific IgE		4 weeks	No
Secondary	Complete blood count (CBC)		4 weeks	No