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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
We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | 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. | 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. | 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. | 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 Combination | Drug | 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. |
|
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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