Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nigella sativa Oil Capsules (100 mg/kg/day), Nigella sativa Oil Capsules (50 mg/kg/day), Fluticasone / Long-Acting Beta-2 Agonist Combination.
- Who it may be relevant to
- Registry conditions: Community Acquired Pneumonia. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 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 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. - Drug Fluticasone / Long-Acting Beta-2 Agonist Combination
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.
Primary outcome measures
- Asthma Control Questionnaire (ACQ) [Time frame: 12 weeks]
- Forced Expiratory Volume in 1 second (FEV₁) [Time frame: 12 weeks]
- Forced Vital Capacity (FVC) [Time frame: 12 weeks]
- FEV₁/FVC ratio [Time frame: 12 weeks]
- Peak Expiratory Flow (PEF) [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07315555 · 36264PR131072/11/25