Not Yet RecruitingNot Applicable

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

90 participantsStarted 2026-01-01

Plain-language 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

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Asthma Control Questionnaire (ACQ)

Timeframe: 12 weeks

Forced Expiratory Volume in 1 second (FEV₁)

Timeframe: 12 weeks

Forced Vital Capacity (FVC)

Timeframe: 12 weeks

FEV₁/FVC ratio

Timeframe: 12 weeks

Peak Expiratory Flow (PEF)

Timeframe: 12 weeks

Trial details

NCT IDNCT07315555

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Community Acquired Pneumonia trials

Plain-language summary

Who can participate

Age range6 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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