Clinical trial NCT02407262: Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Official title: Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
black seed
Nigella sativa
supplementation
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: King Abdulaziz University
First posted: 2015-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 4 weeks
Secondary outcomes:
measure: Serum inflammatory mediators
timeFrame: 4 weeks
measure: Total IgE
timeFrame: 4 weeks
measure: Complete blood count (CBC)
timeFrame: 4 weeks
measure: Pulmonary function test (predicted FEV1%)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
affiliation: University College, London
name: Michael Heinrich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1111/j.1472-8206.2007.00509.x.
citation: 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.
citation: Lebling, R., & Pepperdine, D. (2006). Natural Remedies of Arabia (p. 223). Stacey Intl.
citation: Salama, R. (2010). Clinical and Therapeutic Trials of Nigella Sativa. TAF Preventive Medicine Bulletin, 9(5), 513-522.
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. doi: 10.1080/02770900701247202.
citation: 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.