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

NCT ID: NCT07315555

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-10-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard asthma Controller Therapy Only

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.

Group Type: ACTIVE_COMPARATOR

Nigella sativa Oil Capsules (100 mg/kg/day)

Intervention Type: 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)

Intervention Type: 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 (50 mg/kg/day)

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.

Group Type: EXPERIMENTAL

Nigella sativa Oil Capsules (100 mg/kg/day)

Intervention Type: DIETARY_SUPPLEMENT

Nigella sativa oil administered orally in capsule form at a dose of 100 mg/kg/day as adjunct therapy.

Fluticasone / Long-Acting Beta-2 Agonist Combination

Intervention Type: 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)

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.

Group Type: EXPERIMENTAL

Nigella sativa Oil Capsules (50 mg/kg/day)

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Children aged 6-18 years

2. Diagnosed with moderate persistent asthma according to the Global Initiative for Asthma (GINA) 2022 guidelines

3. Receiving stable standard controller therapy (inhaled corticosteroids ± long-acting β2-agonists) for at least 4 weeks prior to enrollment

4. Able to perform reproducible spirometry

Exclusion Criteria

1. History of severe asthma exacerbation requiring ICU admission in the past 3 months

2. Use of systemic corticosteroids within 4 weeks prior to enrollment

3. Known hypersensitivity to Nigella sativa or its components

4. Other chronic respiratory diseases (e.g., cystic fibrosis, bronchiectasis)

5. Significant comorbidities (e.g., cardiac, renal, or hepatic disorders)

6. Inability to comply with study procedures

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Zaki Elmeazawy

Associate professor of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

36264PR131072/11/25

Identifier Type: -

Identifier Source: org_study_id