This study has been completed.
Sponsor:
University College, London
Collaborator:
King Abdulaziz University
Information provided by (Responsible Party):
Abdulrahman Koshak, University College, London
ClinicalTrials.gov Identifier:
NCT02407262
First received: March 30, 2015
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Condition
Intervention
Phase
Asthma
Dietary Supplement: Black seed oil
Other: Placebo
Phase 2
Study Type:
Interventional
Study Design:
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title:
Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Resource links provided by NLM:
MedlinePlus related topics:
African American Health
U.S. FDA Resources
Further study details as provided by University College, London:
Primary Outcome Measures:
- Asthma Control Test (ACT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum inflammatory mediators [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
- Total IgE [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Complete blood count (CBC) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mainly blood eosinophils
- Pulmonary function test (predicted FEV1%) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Enrollment:
80
Study Start Date:
May 2015
Study Completion Date:
December 2015
Primary Completion Date:
December 2015 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions
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
Eligibility
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: 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
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. 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. Review.
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. Review.
Responsible Party:
Abdulrahman Koshak, Postgraduate researcher, University College, London
ClinicalTrials.gov Identifier:
NCT02407262
History of Changes
Other Study ID Numbers:
6419/002
Study First Received:
March 30, 2015
Last Updated:
May 10, 2016
Health Authority:
Saudi Arabia: Ethics Committee
Keywords provided by 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
ClinicalTrials.gov processed this record on December 16, 2016
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
Inclusion Criteria:
Exclusion Criteria:
This study has been completed.
Sponsor:
University College, London
Collaborator:
King Abdulaziz University
Information provided by (Responsible Party):
Abdulrahman Koshak, University College, London
ClinicalTrials.gov Identifier:
NCT02407262
First received: March 30, 2015
Last updated: May 10, 2016
Last verified: May 2016
Sponsor:
University College, London
Collaborator:
King Abdulaziz University
Information provided by (Responsible Party):
Abdulrahman Koshak, University College, London
ClinicalTrials.gov Identifier:
NCT02407262
First received: March 30, 2015
Last updated: May 10, 2016
Last verified: May 2016
History of Changes
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Dietary Supplement: Black seed oil Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes |
Resource links provided by NLM:
MedlinePlus related topics: African American Health
U.S. FDA Resources
Further study details as provided by University College, London:
Primary Outcome Measures:
- Asthma Control Test (ACT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum inflammatory mediators [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Total IgE [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Complete blood count (CBC) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Pulmonary function test (predicted FEV1%) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | May 2015 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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
- 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 LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02407262
Locations
| Saudi Arabia | |
| King Abdulaziz University Hospital | |
| Jeddah, Saudi Arabia, 21589 | |
University College, London
King Abdulaziz University
Investigators
| Principal Investigator: | Michael Heinrich, PhD | University College, London |
More InformationPublications:
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. 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. Review.
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. Review.
| Responsible Party: | Abdulrahman Koshak, Postgraduate researcher, University College, London |
| ClinicalTrials.gov Identifier: | NCT02407262 History of Changes |
| Other Study ID Numbers: | 6419/002 |
| Study First Received: | March 30, 2015 |
| Last Updated: | May 10, 2016 |
| Health Authority: | Saudi Arabia: Ethics Committee |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on December 16, 2016
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
Inclusion Criteria:
Exclusion Criteria:
