AsthmaPhase 2NCT02407262
Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
A Phase 2 study testing Black seed oil in people with Asthma, run by University College, London at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Black seed oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Asthma
- Being tested
- Black seed oil, Placebo
- Keywords
- asthma, black seed, Nigella sativa, supplementation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black seed oilDietary supplement
Also called Nigella sativa oil
PlaceboOther
vegetable oil
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Black seed oil capsules
1g/day for 4 weeks Receives: Dietary Supplement: Black seed oil |
| Placebo | Placebo comparator | Placebo (olive oil) capsules
1g/day for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
Measured: 4 weeks
Secondary outcomes (4)
Serum inflammatory mediators
IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
Measured: 4 weeks
Total IgE
Measured: 4 weeks
Complete blood count (CBC)
Mainly blood eosinophils
Measured: 4 weeks
Pulmonary function test (predicted FEV1%)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz University
- Responsible party
- Principal investigator, Abdulrahman Koshak, University College, London
- Investigators
- Michael Heinrich, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407262
- Sponsor's protocol ID
- 6419/002
- Status last verified
- May 2016
- First submitted
- 30 Mar 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19561905Al-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.
PubMed 23189095Boskabady 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.
PubMed 17868210Salem 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.
PubMed 16275613Lebling, 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.
PubMed 17994396Koshak 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.
PubMed 28093815
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
- ClinicalTrials.gov ID
- NCT02407262
- Acronym / sponsor ID
- 6419/002
- Conditions
- Asthma
- Keywords
- asthma, black seed, Nigella sativa, supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- King Abdulaziz University
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Dietary Supplement: Black seed oilBlack seed oil capsules 1g/day for 4 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (olive oil) capsules 1g/day for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black seed oilAlso: Nigella sativa oil | Dietary supplement | Treatment |
| Placebovegetable oil | Other | Placebo |
Primary outcome
Asthma Control Test (ACT)
Time frame: 4 weeks
4 secondary outcomes
Serum inflammatory mediators
Time frame: 4 weeks
Total IgE
Time frame: 4 weeks
Complete blood count (CBC)
Time frame: 4 weeks
Pulmonary function test (predicted FEV1%)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 19561905Al 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.
- Background: PubMed 23189095Al-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.
- Background: PubMed 17868210Boskabady 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.
- Background: PubMed 16275613Salem 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.
- BackgroundLebling, R., & Pepperdine, D. (2006). Natural Remedies of Arabia (p. 223). Stacey Intl.
- BackgroundSalama, R. (2010). Clinical and Therapeutic Trials of Nigella Sativa. TAF Preventive Medicine Bulletin, 9(5), 513-522.
- Background: PubMed 17994396Singh 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.
- Derived from this study: PubMed 28093815Koshak 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Heinrich, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Black seed oil in people with Asthma, run by University College, London at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407262, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.