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

Rehab Zaki Elmeazawy

Status: Enrolling

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

Treatments: Drug: Nigella Sativa Oil capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05952102

Nigella Sativa in Pneumonia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

52 children with community acquired pneumonia will receive Nigella sativa oil capsules

Experimental group

Description:

52 children with community-acquired pneumonia will receive Nigella sativa oil in capsules at a dose of 40 mg/kg/day (8), as an adjunct therapy to the usual pneumonia treatment till the recovery of the disease.

Treatment:

Drug: Nigella Sativa Oil capsule

52 children

No Intervention group

Description:

52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group