NCT07315555

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2026-10-31
• First posted: 2026-01-02
• Last updated: 2026-01-02