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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 52 children with community acquired pneumonia will receive Nigella sativa oil capsules | Experimental | 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. |
|
| 52 children | No Intervention | 52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella Sativa Oil capsule | Drug | Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Discharge or death of the patient | 30 days |
| Pneumonia complications | Occurrence of pneumonia complications | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rehab Zaki Elmeazawy, MD | Contact | 01004815280 | rehab.elmeazawy@med.tanta.edu.eg | |
| Ahmed A. Aboelezz, MD | Contact | 01005323714 | ahmed.abouelaaz1@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Asmaa E. Fayed, MBBS | Tanta University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Recruiting | Tanta | Gharbia Governorate | 31527 | Egypt |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
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