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
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedFebruary 14, 2024
February 1, 2024
9 months
July 11, 2023
February 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Mortality
30 days
Pneumonia complications
30 days
Study Arms (2)
52 children with community acquired pneumonia will receive Nigella sativa oil capsules
EXPERIMENTAL52 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 INTERVENTION52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group
Interventions
Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Tanta, Gharbia Governorate, 31527, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Asmaa E. Fayed, MBBS
Tanta University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 19, 2023
Study Start
August 1, 2023
Primary Completion
May 1, 2024
Study Completion
August 1, 2024
Last Updated
February 14, 2024
Record last verified: 2024-02