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

Study Overview

• Status: Not yet recruiting
• Conditions: Community Acquired Pneumonia
• Intervention / Treatment: Dietary supplement: Nigella sativa Oil Capsules (100 mg/kg/day); Dietary supplement: Nigella sativa Oil Capsules (50 mg/kg/day); Drug: Fluticasone / Long-Acting Beta-2 Agonist Combination

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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.; 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.
Experimental: 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.	Dietary supplement: 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.; Drug: 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.
Experimental: 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.	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pneumonia; Pediatric; Nigella sativa
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Community-Acquired Infections; Pneumonia; Community-Acquired Pneumonia; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstadienes; Androstenes; Androstanes; Fluticasone; Nigella sativa oil
• Other Study ID Numbers: 36264PR131072/11/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No