Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Black seed oil
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, black seed, Nigella sativa, supplementation
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
Sites / Locations
- King Abdulaziz University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Black seed oil capsules 1g/day for 4 weeks
Placebo (olive oil) capsules 1g/day for 4 weeks
Outcomes
Primary Outcome Measures
Asthma Control Test (ACT)
Secondary Outcome Measures
Serum inflammatory mediators
IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
Total IgE
Complete blood count (CBC)
Mainly blood eosinophils
Pulmonary function test (predicted FEV1%)
Full Information
NCT ID
NCT02407262
First Posted
March 30, 2015
Last Updated
May 10, 2016
Sponsor
University College, London
Collaborators
King Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT02407262
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College, London
Collaborators
King Abdulaziz University
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, black seed, Nigella sativa, supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Black seed oil capsules
1g/day for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (olive oil) capsules
1g/day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Black seed oil
Other Intervention Name(s)
Nigella sativa oil
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
vegetable oil
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Serum inflammatory mediators
Description
IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
Time Frame
4 weeks
Title
Total IgE
Time Frame
4 weeks
Title
Complete blood count (CBC)
Description
Mainly blood eosinophils
Time Frame
4 weeks
Title
Pulmonary function test (predicted FEV1%)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Heinrich, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdulaziz University Hospital
City
Jeddah
ZIP/Postal Code
21589
Country
Saudi Arabia
12. IPD Sharing Statement
Citations:
PubMed Identifier
19561905
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.
Results Reference
background
PubMed Identifier
23189095
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.
Results Reference
background
PubMed Identifier
17868210
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. Erratum In: Fundam Clin Pharmacol. 2008 Feb;22(1):105.
Results Reference
background
PubMed Identifier
16275613
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.
Results Reference
background
Citation
Lebling, R., & Pepperdine, D. (2006). Natural Remedies of Arabia (p. 223). Stacey Intl.
Results Reference
background
Citation
Salama, R. (2010). Clinical and Therapeutic Trials of Nigella Sativa. TAF Preventive Medicine Bulletin, 9(5), 513-522.
Results Reference
background
PubMed Identifier
17994396
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.
Results Reference
background
PubMed Identifier
28093815
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.
Results Reference
derived
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Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
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