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

NCT07315555 | Not Yet Recruiting

• 1 other identifier: 36264PR131072/11/25
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Community Acquired Pneumonia

Keywords

Nigella sativa; Pneumonia; Pediatric

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

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.

Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day); Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day)

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.

Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day); Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination

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.

Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day); Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination

Interventions

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.

Standard Therapy + Nigella sativa (100 mg/kg/day); Standard asthma Controller Therapy Only

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.

Standard Therapy + Nigella sativa (50 mg/kg/day); Standard asthma Controller Therapy Only

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.

Standard Therapy + Nigella sativa (100 mg/kg/day); Standard Therapy + Nigella sativa (50 mg/kg/day)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Significant comorbidities (e.g., cardiac, renal, or hepatic disorders)
• Inability to comply with study procedures

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia

Interventions

Nigella sativa oil; Fluticasone

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pediatrics

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share