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

Study Overview
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Brief Summary
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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
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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: Discharge or death of the patient. Occurrence of pneumonia complications.

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

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

Intervention / Treatment
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* Drug: Nigella Sativa Oil capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 52 children with community acquired pneumonia will receive Nigella sativa oil capsules<br>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. | Drug: Nigella Sativa Oil capsule<br>* Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia<br>* Other names: Black seed oil capsule;|
| No Intervention: 52 children<br>52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | Time taken for normalization of respiratory rate | 3 days | 
| Temperature | Duration of defeverness | 3 days | 
| Oxygen saturation | Duration of normal oxygen saturation | 3 days | 
| Feeding | Duration of improvement of feeding | 3 days | 
| Respiratory distress | Duration of improvement of respiratory distress | 7 days | 
| Hospital stays | Duration of hospital stay | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Discharge or death of the patient | 30 days | 
| Pneumonia complications | Occurrence of pneumonia complications | 30 days |