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Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05952102
Enrollment
104
Registered
2023-07-19
Start date
2023-08-01
Completion date
2024-08-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia

Keywords

Nigella Sativa Oil, Pneumonia

Brief summary

Nigella sativa is the world's oldest immunomodulator. The main active component in Nigella sativa is thymoquinone. Research shows thymoquinone has antioxidant, anti-inflammatory, and antimicrobial effects. Based on these observations on the pharmacological activities of Nigella sativa, the potential therapeutic efficacy of N. Sativa was proposed in CAP.

Detailed description

The aim of this work is to assess the benefit of oral Nigella Sativa oil supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with pneumonia admitted to the Pulmonology Unit, Pediatric Department. Primary outcome: 1- The duration of clinical manifestations of pneumonia including time taken for normalization of respiratory rate, temperature, and oxygen. saturation, chest in drawing, hypoxia, lethargy, and inability to feed 2- The duration of hospital stay. Secondary outcome: 1. Discharge or death of the patient. 2. Occurrence of pneumonia complications.

Interventions

Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

Sponsors

Rehab Zaki Elmeazawy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
2 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* Signs and symptoms of lower respiratory tract infections (LRTI) (LRTI was defined as ≥ 1 of the following: new or different cough or sputum production, chest pain, dyspnea, tachypnea, or abnormal auscultatory findings). * Focal findings on chest x-ray indicating pneumonia.

Exclusion criteria

* Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorder impacting respiration i.e. genetic, metabolic, neuromuscular disorders….etc, children with CHD affecting the pulmonary blood flow

Design outcomes

Primary

MeasureTime frameDescription
Hospital stays14 daysDuration of hospital stay
Feeding3 daysDuration of improvement of feeding
Respiratory distress7 daysDuration of improvement of respiratory distress
Respiratory rate3 daysTime taken for normalization of respiratory rate
Temperature3 daysDuration of defeverness
Oxygen saturation3 daysDuration of normal oxygen saturation

Secondary

MeasureTime frameDescription
Pneumonia complications30 daysOccurrence of pneumonia complications
Mortality30 daysDischarge or death of the patient

Countries

Egypt

Contacts

Primary ContactRehab Zaki Elmeazawy, MD
rehab.elmeazawy@med.tanta.edu.eg01004815280
Backup ContactAhmed A. Aboelezz, MD
ahmed.abouelaaz1@med.tanta.edu.eg01005323714

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026