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

Tanta University

Status: Not yet enrolling

Conditions: Community Acquired Pneumonia

Treatments: Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination; Dietary Supplement: Nigella sativa Oil Capsules (50 mg/kg/day); Dietary Supplement: Nigella sativa Oil Capsules (100 mg/kg/day)

Study type: Interventional

Funder types: Other

Identifiers

NCT07315555

36264PR131072/11/25

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Standard asthma Controller Therapy Only

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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

Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination