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

ConditionCommunity Acquired Pneumonia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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 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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Standard asthma Controller Therapy OnlyActive comparator 2 interventions
Group B: Standard Therapy + Nigella sativa (50 mg/kg/day)Experimental treatment 2 interventions
Group C: Standard Therapy + Nigella sativa (100 mg/kg/day)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Asthma Control Questionnaire (ACQ)

Time frame
12 weeks
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: