Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
- Conditions
- Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia
- Interventions
- Drug: Nigella Sativa Oil capsule
- Registration Number
- NCT05952102
- Lead Sponsor
- Rehab Zaki Elmeazawy
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 52 children with community acquired pneumonia will receive Nigella sativa oil capsules Nigella Sativa Oil capsule 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.
- Primary Outcome Measures
Name Time Method Temperature 3 days Duration of defeverness
Oxygen saturation 3 days Duration of normal oxygen saturation
Respiratory rate 3 days Time taken for normalization of respiratory rate
Feeding 3 days Duration of improvement of feeding
Respiratory distress 7 days Duration of improvement of respiratory distress
Hospital stays 14 days Duration of hospital stay
- Secondary Outcome Measures
Name Time Method Mortality 30 days Discharge or death of the patient
Pneumonia complications 30 days Occurrence of pneumonia complications
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Tanta, Gharbia, Egypt