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

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.

Study Overview

• Status: Recruiting
• Conditions: Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pneumonia
• Intervention / Treatment: Drug: Nigella Sativa Oil capsule

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rehab Zaki Elmeazawy, MD; Phone Number: 01004815280; Email: rehab.elmeazawy@med.tanta.edu.eg
• Study Contact Backup: Name: Ahmed A. Aboelezz, MD; Phone Number: 01005323714; Email: ahmed.abouelaaz1@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31527
      • Recruiting
      • Faculty of medicine
      • Contact: Rehab Zaki Elmeazawy, MD; Phone Number: 01004815280; Email: rehab.elmeazawy@med.tanta.edu.eg
      • Contact: Ahmed A. Aboelezz, MD; Phone Number: 01005323714; Email: ahmed.abouelaaz1@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rehab Zaki Elmeazawy
• Investigators: Study Chair: Asmaa E. Fayed, MBBS, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; Nigella Sativa Oil
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: Nigella Sativa in Pneumonia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No