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Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs

Primary Purpose

Dengue Fever With Warning Signs

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Melatonin 20 MG
Sponsored by
Ilocos Training and Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dengue Fever With Warning Signs

Eligibility Criteria

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

Inclusion Criteria:

  • 1. Patient aged 5 to 18 years old with febrile episodes (Temperature >/= 37.8 degrees Celsius) with positive Dengue NS1.

    2. Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following:

    1. Abdominal tenderness
    2. Persistent vomiting
    3. Minimal mucosal bleed
    4. Platelet count less than or equal to 100,000

      Exclusion Criteria:

  • 1. Patients with signs and symptoms related to dengue fever but with negative Dengue Ns1 result.

    2. Patients diagnosed as Severe Dengue or Dengue Shock. 3. Patients unable to tolerate tablet formulation. 4. Patients placed on nothing per Orem. 5. Patients previously treated in a referring facility.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    Other than the guided management of Dengue Fever with warning signs, the treatment group will receive a standard dose of 20mg/day of melatonin20-21 for 5 days. The dosing was based on the study by Leiberman et al and Malhotra et al. If a patient is unable to tolerate the whole or punctured tablet, it will be given with milk or water. There is no known interaction between melatonin and milk known to date. Daily complete blood count will be done and be recording in an electronic record using Microsoft Excel.

    Other than the guided management of Dengue Fever with warning signs, the control group will be manage according the Department of Health Dengue Management Guideline. No placebo will be given.

    Outcomes

    Primary Outcome Measures

    Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
    Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs

    Secondary Outcome Measures

    Incidence Of Dengue Fever with Warning Signs among Pediatric Population at Ilocos Training and Regional Medical Center.
    Clinical Profiles Of Pediatric Patients Diagnosed With Dengue Fever With Warning Signs In Ilocos Training And Regional Medical Center
    determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs
    Number of days for the platelet count to increase from the 1st day of administration of melatonin Number of days for the white blood cell count to increase from the 1st day of administration of melatonin Absence of subsequent complications in the critical phase of the illness (4th - 6th day of illness) i. Presence of mucosal bleeding, melena, epistaxis ii. Presence of ascites, pleural effusion, edema iii. Hypotension, tachycardia iv. Increase capillary refill time
    Number Of Days Prior To Elevation of White Blood Cells Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
    Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs

    Full Information

    First Posted
    August 22, 2021
    Last Updated
    October 12, 2021
    Sponsor
    Ilocos Training and Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05034809
    Brief Title
    Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Dengue Fever With Warning Signs
    Official Title
    Effectiveness Of High Dose Melatonin As Adjunctive Therapy For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2021 (Anticipated)
    Primary Completion Date
    August 30, 2022 (Anticipated)
    Study Completion Date
    October 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ilocos Training and Regional Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action. This is a randomized control trial to determine the effectiveness of adjunctive melatonin therapy among patients diagnosed with Dengue fever with Warning Signs. This would include children aged 5 to 18 years old with no signs of hemmorhagic shock. They would be randomly assigned into 2 groups. Baseline Complete blood count with platelet (CBCPC) will be collected. Daily CBCPC will be collected and would be statistically analyze after the study.
    Detailed Description
    Dengue Hemorrhagic Fever is a mosquito-borne viral disease endemic in the Philippines which caused multiple epidemics. Most points to the activation of the complement system secondary to humoral respond leading to cytokine release causing systemic inflammation. Melatonin, is a hormone which has an a) anti-viral, b) immunomodulator, c) antioxidant, d) modulatory effect on hematopoiesis and e) anti-inflammatory action. Main Objective: To determine the effectiveness of Melatonin tablet as an adjunctive therapy in decreasing morbidity for pediatric patients diagnosed with Dengue Fever with Warning Signs at Ilocos Training and Regional Medical Center Department of Pediatrics. Specific Objective To determine the clinical profiles of pediatric patients diagnosed with Dengue Fever with Warning Signs in Ilocos Training and Regional Medical Center To determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs with regards to: a. Number of days for resolution of fever from the 1st day of administration of melatonin b. Number of days for the platelet count to increase from the 1st day of administration of melatonin c. Number of days for the white blood cell count to increase from the 1st day of administration of melatonin d. Absence of subsequent complications in the critical phase of the illness (4th - 6th day of illness) i. Presence of mucosal bleeding, melena, epistaxis ii. Presence of ascites, pleural effusion, edema iii. Hypotension, tachycardia iv. Increase capillary refill time

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dengue Fever With Warning Signs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    Investigator
    Masking Description
    The research assistant will explain to the parents and to the child if capable of understanding the clinical trial. However, the participants, family and the researcher will not know until the end of the study if they were placed in the control group or treatment group. Blinding will be done using a pre-generated number code and QR code which, when scanned by the research assistant at the end of the study, it will reveal to what group the patient was randomized.
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    Other than the guided management of Dengue Fever with warning signs, the treatment group will receive a standard dose of 20mg/day of melatonin20-21 for 5 days. The dosing was based on the study by Leiberman et al and Malhotra et al. If a patient is unable to tolerate the whole or punctured tablet, it will be given with milk or water. There is no known interaction between melatonin and milk known to date. Daily complete blood count will be done and be recording in an electronic record using Microsoft Excel.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Other than the guided management of Dengue Fever with warning signs, the control group will be manage according the Department of Health Dengue Management Guideline. No placebo will be given.
    Intervention Type
    Drug
    Intervention Name(s)
    Melatonin 20 MG
    Intervention Description
    Melatonin, also known as N-acetyl-5-methoxytryptamine will be the main intervention given to participating patients of this study. This study will use a dose of 20mg/day using the commercially available 5mg/tablet20-21. If a patient cannot be tolerate swallowing the whole tablet, it will be crushed and mixed with milk. According to the study done by Shah et al. there was no degradation in the active component of melatonin when mixed with milk or food as a medium for drug delivery.
    Primary Outcome Measure Information:
    Title
    Number Of Days Prior To Elevation of Platelet Count Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
    Description
    Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Incidence Of Dengue Fever with Warning Signs among Pediatric Population at Ilocos Training and Regional Medical Center.
    Description
    Clinical Profiles Of Pediatric Patients Diagnosed With Dengue Fever With Warning Signs In Ilocos Training And Regional Medical Center
    Time Frame
    1 year
    Title
    determine the effectiveness of Melatonin 20mg as adjunctive therapy for pediatric patients diagnosed with Dengue Fever with Warning Signs
    Description
    Number of days for the platelet count to increase from the 1st day of administration of melatonin Number of days for the white blood cell count to increase from the 1st day of administration of melatonin Absence of subsequent complications in the critical phase of the illness (4th - 6th day of illness) i. Presence of mucosal bleeding, melena, epistaxis ii. Presence of ascites, pleural effusion, edema iii. Hypotension, tachycardia iv. Increase capillary refill time
    Time Frame
    1 year
    Title
    Number Of Days Prior To Elevation of White Blood Cells Among Dengue Fever with Warningn Signs Patient Given Melatonin 20mg.
    Description
    Effectiveness Of Melatonin Tablet As An Adjunctive Therapy In Decreasing Morbidity For Pediatric Patients Diagnosed With Dengue Fever With Warning Signs
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Patient aged 5 to 18 years old with febrile episodes (Temperature >/= 37.8 degrees Celsius) with positive Dengue NS1. 2. Patients with Dengue Fever on the Department of Health 2012 definition of Dengue fever with Warning Signs with any one of the following: Abdominal tenderness Persistent vomiting Minimal mucosal bleed Platelet count less than or equal to 100,000 Exclusion Criteria: 1. Patients with signs and symptoms related to dengue fever but with negative Dengue Ns1 result. 2. Patients diagnosed as Severe Dengue or Dengue Shock. 3. Patients unable to tolerate tablet formulation. 4. Patients placed on nothing per Orem. 5. Patients previously treated in a referring facility.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Navid P Roodaki, MD
    Phone
    +63 917 309 3931
    Email
    navidroodaki2391@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ma. Lydia O Ramirez, MD
    Organizational Affiliation
    Ilocos Training and Regional Medical Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Due to the Data Privacy Act of the Philippines, only the completed data will be shared

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