Efficacy of Oral Nigella Sativa as Adjuvant Therapy in Children With Moderate Persistent Asthma

N/ANot Yet RecruitingNCT07315555

Tanta University90 enrolled

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

We hypothesize that supplementation with Nigella sativa will lead to improved asthma control scores and enhanced pulmonary function parameters in this population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Community Acquired Pneumonia

Interventions

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children aged 6-18 years 2. Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines 3. Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment 4. Able to perform reproducible spirometry Exclusion Criteria: 1. History of severe asthma exacerbation requiring ICU admission in the past 3 months 2. Use of systemic corticosteroids within 4 weeks prior to enrollment 3. Known hypersensitivity to Nigella sativa or its components 4. Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis) 5. Significant comorbidities (e.g., cardiac, renal, or hepatic disorders) 6. Inability to comply with study procedures

Outcomes

Primary Outcomes

Asthma Control Questionnaire (ACQ)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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