Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07315555

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Asthma Control Questionnaire (ACQ)

    Time frame: 12 weeks

  2. Forced Expiratory Volume in 1 second (FEV₁)

    Time frame: 12 weeks

    Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

  3. Forced Vital Capacity (FVC)

    Time frame: 12 weeks

    Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

  4. FEV₁/FVC ratio

    Time frame: 12 weeks

    Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

  5. Peak Expiratory Flow (PEF)

    Time frame: 12 weeks

    Pulmonary function will be assessed using standard spirometry performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Acronym: Asthma

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.