search
Back to results

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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nigella Sativa Oil capsule
Sponsored by
Rehab Zaki Elmeazawy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

Eligibility Criteria

2 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    52 children with community acquired pneumonia will receive Nigella sativa oil capsules

    52 children

    Arm Description

    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 with community-acquired pneumonia with the usual pneumonia treatment as a control group

    Outcomes

    Primary Outcome Measures

    Respiratory rate
    Time taken for normalization of respiratory rate
    Temperature
    Duration of defeverness
    Oxygen saturation
    Duration of normal oxygen saturation
    Feeding
    Duration of improvement of feeding
    Respiratory distress
    Duration of improvement of respiratory distress
    Hospital stays
    Duration of hospital stay

    Secondary Outcome Measures

    Mortality
    Discharge or death of the patient
    Pneumonia complications
    Occurrence of pneumonia complications

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Rehab Zaki Elmeazawy
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05952102
    Brief Title
    Nigella Sativa as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
    Official Title
    Role of Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rehab Zaki Elmeazawy

    4. Oversight

    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

    5. 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.
    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: Discharge or death of the patient. Occurrence of pneumonia complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    52 children with community acquired pneumonia will receive Nigella sativa oil capsules
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    52 children
    Arm Type
    No Intervention
    Arm Description
    52 children with community-acquired pneumonia with the usual pneumonia treatment as a control group
    Intervention Type
    Drug
    Intervention Name(s)
    Nigella Sativa Oil capsule
    Other Intervention Name(s)
    Black seed oil capsule
    Intervention Description
    Nigella Sativa Oil as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia
    Primary Outcome Measure Information:
    Title
    Respiratory rate
    Description
    Time taken for normalization of respiratory rate
    Time Frame
    3 days
    Title
    Temperature
    Description
    Duration of defeverness
    Time Frame
    3 days
    Title
    Oxygen saturation
    Description
    Duration of normal oxygen saturation
    Time Frame
    3 days
    Title
    Feeding
    Description
    Duration of improvement of feeding
    Time Frame
    3 days
    Title
    Respiratory distress
    Description
    Duration of improvement of respiratory distress
    Time Frame
    7 days
    Title
    Hospital stays
    Description
    Duration of hospital stay
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Discharge or death of the patient
    Time Frame
    30 days
    Title
    Pneumonia complications
    Description
    Occurrence of pneumonia complications
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs