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

Sponsor
Rehab Zaki Elmeazawy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05952102
Collaborator
(none)
104
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nigella Sativa Oil capsule
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Respiratory rate [3 days]

      Time taken for normalization of respiratory rate

    2. Temperature [3 days]

      Duration of defeverness

    3. Oxygen saturation [3 days]

      Duration of normal oxygen saturation

    4. Feeding [3 days]

      Duration of improvement of feeding

    5. Respiratory distress [7 days]

      Duration of improvement of respiratory distress

    6. Hospital stays [14 days]

      Duration of hospital stay

    Secondary Outcome Measures

    1. Mortality [30 days]

      Discharge or death of the patient

    2. Pneumonia complications [30 days]

      Occurrence of pneumonia complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rehab Zaki Elmeazawy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Zaki Elmeazawy, Doctor, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05952102
    Other Study ID Numbers:
    • Nigella Sativa in Pneumonia
    First Posted:
    Jul 19, 2023
    Last Update Posted:
    Jul 19, 2023
    Last Verified:
    Jul 1, 2023
    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
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Jul 19, 2023