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

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

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

Treatments tested in this trial

  • Nigella sativa Oil Capsules (100 mg/kg/day)
  • Nigella sativa Oil Capsules (50 mg/kg/day)
  • Fluticasone / Long-Acting Beta-2 Agonist Combination

Treatment groups

90 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators