Community Acquired PneumoniaAsthmaNCT07315555
Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma
A study testing Nigella sativa Oil Capsules (100 mg/kg/day), Nigella sativa Oil Capsules (50 mg/kg/day) and Fluticasone / Long-Acting Beta-2 Agonist Combination in people with Community Acquired Pneumonia, run by Tanta University.
Trial summary
Complementary and adjunctive therapies are increasingly being explored to enhance asthma control and reduce airway inflammation. Nigella sativa (black seed) is a medicinal plant used traditionally in multiple regions and has demonstrated anti-inflammatory, immunomodulatory, and bronchodilator effects. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Nigella sativa Oil Capsules (100 mg/kg/day), Nigella sativa Oil Capsules (50 mg/kg/day) and Fluticasone / Long-Acting Beta-2 Agonist Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6-18 years
- Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines
- Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment
- Able to perform reproducible spirometry
Who cannot join
- History of severe asthma exacerbation requiring ICU admission in the past 3 months
- Use of systemic corticosteroids within 4 weeks prior to enrollment
- Known hypersensitivity to Nigella sativa or its components
- Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis)
- Significant comorbidities (e.g., cardiac, renal, or hepatic disorders)
- Inability to comply with study procedures
About this study
Complementary and adjunctive therapies are increasingly being explored to enhance asthma control and reduce airway inflammation. Nigella sativa (black seed) is a medicinal plant used traditionally in multiple regions and has demonstrated anti-inflammatory, immunomodulatory, and bronchodilator effects. Its potential as an adjuvant therapy in asthma has attracted attention in both preclinical and clinical research
Read the detailed description
We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.
- Conditions
- Community Acquired Pneumonia
- Being tested
- Nigella sativa Oil Capsules (100 mg/kg/day), Nigella sativa Oil Capsules (50 mg/kg/day), Fluticasone / Long-Acting Beta-2 Agonist Combination
- Keywords
- Nigella sativa, Pneumonia, Pediatric
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativa Oil Capsules (100 mg/kg/day)Dietary supplement
Nigella sativa oil administered orally in capsule form at a dose of 100 mg/kg/day as adjunct therapy.
Nigella sativa Oil Capsules (50 mg/kg/day)Dietary supplement
Nigella sativa oil administered orally in capsule form at a dose of 50 mg/kg/day as adjunct therapy.
Fluticasone / Long-Acting Beta-2 Agonist CombinationDrug
Low-dose inhaled corticosteroid (fluticasone propionate 200 µg/day) combined with a long-acting beta-2 agonist (two puffs every 12 hours), administered via metered-dose inhaler with spacer.
| Study group | Role | What they receive |
|---|---|---|
| Standard asthma Controller Therapy Only | Active comparator | 30 children with moderate persistent asthma receiving standard controller therapy consisting of a combined low-dose inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA), administered by metered-dose inhaler with spacer. Receives: Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day); Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day) |
| Standard Therapy + Nigella sativa (50 mg/kg/day) | Experimental | 30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 50 mg/kg/day as adjunct therapy. Receives: Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day); Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination |
| Standard Therapy + Nigella sativa (100 mg/kg/day) | Experimental | 30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 100 mg/kg/day as adjunct therapy. Receives: Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day); Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire (ACQ)
Measured: 12 weeks
Forced Expiratory Volume in 1 second (FEV₁)
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: 12 weeks
Forced Vital Capacity (FVC)
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: 12 weeks
FEV₁/FVC ratio
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: 12 weeks
Peak Expiratory Flow (PEF)
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Zaki Elmeazawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315555
- Sponsor's protocol ID
- 36264PR131072/11/25
- Acronym
- Asthma
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT07315555
- Acronym / sponsor ID
- Asthma / 36264PR131072/11/25
- Conditions
- Community Acquired Pneumonia
- Keywords
- Nigella sativa, Pneumonia, Pediatric
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- 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.
Complementary and adjunctive therapies are increasingly being explored to enhance asthma control and reduce airway inflammation. Nigella sativa (black seed) is a medicinal plant used traditionally in multiple regions and has demonstrated anti-inflammatory, immunomodulatory, and bronchodilator effects. Its potential as an adjuvant therapy in asthma has attracted attention in both preclinical and clinical research
Detailed description
We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard asthma Controller Therapy Only | Active comparator | Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day), Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day)30 children with moderate persistent asthma receiving standard controller therapy consisting of a combined low-dose inhaled corticosteroid (ICS) and long-acting β2-agonist (LABA), administered by metered-dose inhaler with spacer. |
| Standard Therapy + Nigella sativa (50 mg/kg/day) | Experimental | Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day), Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 50 mg/kg/day as adjunct therapy. |
| Standard Therapy + Nigella sativa (100 mg/kg/day) | Experimental | Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day), Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination30 children with moderate persistent asthma receiving standard controller therapy plus Nigella sativa oil capsules at a dose of 100 mg/kg/day as adjunct therapy. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 6-18 years
- Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines
- Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment
- Able to perform reproducible spirometry
Key exclusion criteria (6 listed)
- History of severe asthma exacerbation requiring ICU admission in the past 3 months
- Use of systemic corticosteroids within 4 weeks prior to enrollment
- Known hypersensitivity to Nigella sativa or its components
- Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis)
- Significant comorbidities (e.g., cardiac, renal, or hepatic disorders)
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 |
|---|---|---|
| Nigella sativa Oil Capsules (100 mg/kg/day)Nigella sativa oil administered orally in capsule form at a dose of 100 mg/kg/day as adjunct therapy. | Dietary supplement | Standard Therapy + Nigella sativa (50 mg/kg/day), Standard asthma Controller Therapy Only |
| Nigella sativa Oil Capsules (50 mg/kg/day)Nigella sativa oil administered orally in capsule form at a dose of 50 mg/kg/day as adjunct therapy. | Dietary supplement | Standard Therapy + Nigella sativa (100 mg/kg/day), Standard asthma Controller Therapy Only |
| Fluticasone / Long-Acting Beta-2 Agonist CombinationLow-dose inhaled corticosteroid (fluticasone propionate 200 µg/day) combined with a long-acting beta-2 agonist (two puffs every 12 hours), administered via metered-dose inhaler with spacer. | Drug | Standard Therapy + Nigella sativa (100 mg/kg/day), Standard Therapy + Nigella sativa (50 mg/kg/day) |
Primary outcome
Asthma Control Questionnaire (ACQ)
Time frame: 12 weeks
Forced Expiratory Volume in 1 second (FEV₁)
Time frame: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Forced Vital Capacity (FVC)
Time frame: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
FEV₁/FVC ratio
Time frame: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Peak Expiratory Flow (PEF)
Time frame: 12 weeks
Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Community Acquired Pneumonia
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella sativa Oil Capsules (100 mg/kg/day), Nigella sativa Oil Capsules (50 mg/kg/day) and Fluticasone / Long-Acting Beta-2 Agonist Combination in people with Community Acquired Pneumonia, run by Tanta University.
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: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Questionnaire (ACQ) (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.