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Clinical Study of Reduning Injection for the Treatment of Influenza in Children

Primary Purpose

Influenza in Children

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Reduning injection
Oseltamivir phosphate granules
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza in Children focused on measuring Reduning injection, efficacy and safety, time of temperature recovery, randomized, double blind, parallel control, multi-center clinical study

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. With clinical manifestations of influenza.A rapid detection for virus antigen of influenza result is positive.
  2. The patients were suffered from influenza within 48 hours.
  3. Subjects aged 2 ~14 years old.
  4. Before inclusion into the study, The patient's temperature was over 38 ℃.
  5. The guardian agreed to participate in this project and signed the informed consent.Patients aged 8 years old or above with their own wishes must be respected.

Exclusion Criteria:

  1. Patients with severe or critical illness of influenza.
  2. Patients with pneumonia, combined pharyngeal membrane fever, herpetic pharyngitis, suppurative tonsillitis and other diseases.
  3. Patients were diagnosed with mycoplasma infection with pharyngeal swab positive or meet the conditions of bacterial infection:White Blood Count(WBC) exceeded 20% of the upper limit of normal range, accompanied by neutrophils increased and serum PCT≥2ug/L, etc.
  4. Serum creatinine(SCR) exceeds the upper limit of normal range.Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST) exceeded the normal range by more than 2 times.
  5. Patients with severe malnutrition, rickets and severe primary diseases of heart, brain, liver, kidney and hematopoietic system.
  6. Patients with immunodeficiency or taking glucocorticoid.Patients take other immunosuppressive drugs within the last week.
  7. Before be included,patient was taken Oseltamivir or traditional Chinese medicine was used to clear away heat and toxic material within 24 hours.
  8. Severely infected persons who must be treated with other antiviral drugs.
  9. Allergic to the Reduning injection or Oseltamivir phosphate granules.
  10. According to the judgment of the researcher, the patients can cause loss of follow-up should be excluded,such as patients with unstable living environment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Reduning injection +Oseltamivir phosphate granule simulants

    Oseltamivir phosphate granules+ Reduning injection simulants

    Outcomes

    Primary Outcome Measures

    The time of temperature recovery.
    The patients who suffered from influenza were observed their time of temperature recovery .After the first use of the drug,record the time that the patient's temperature dropped to < 37.3℃.The time required for no recurrence within 24 hours.It was the point that evaluated the end of the treatment.

    Secondary Outcome Measures

    The time when the fever begins to subside
    The time required for the first drop of body temperature to reach or exceed 0.5℃.
    The time of disease to alleviate
    The symptom score of each symptom after treatment is 0 or mild and lasts for more than 24 hours.The symptom score is recorded daily.
    The degree of disease remission
    According to the"clinical symptom record table", all symptoms were scored.Daily records were recorded to calculate the decrease scores of the total daily symptom score each day.The median time was plotted to calculate Area Under the Curve(AUC) to represent the degree of symptom relief.
    The disappearance rate of individual symptoms
    After medication,patients were asked to evaluate the presence or disappearance of each symptoms (such as fever, headache, body pain, fatigue, pharynx pain, nasal congestion, runny nose, sweating, thirst, cough) of the Influenza.
    The rate of negative conversion of Influenza viral
    The baseline and the end point of treatment were tested for influenza virus in pharyngeal swab.
    The number of antipyretic and analgesic drugs used
    Evaluate the number of combined antipyretic and analgesic drugs used after medication.
    The incidence of severe/complications of influenza
    As the end point of the test,collect data of each participants and calculate the incidence rate of severe/complications of influenza.
    Frequency of antipyretic and analgesic drugs used
    Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.

    Full Information

    First Posted
    November 22, 2019
    Last Updated
    December 3, 2019
    Sponsor
    China Academy of Chinese Medical Sciences
    Collaborators
    Children's Hospital of Soochow University, Anhui Provincial Children's Hospital, Qilu Children's Hospital of Shandong University, Tianjin 4th Centre Hospital, Renmin Hospital of Wuhan University, Hebei Maternity&Child Healthcare Hospital, The Second Affiliated Hospital of Jiaxing University, The First Hospital of Hunan University of Chinese Medicine, Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04183725
    Brief Title
    Clinical Study of Reduning Injection for the Treatment of Influenza in Children
    Official Title
    Reduning Injection for the Treatment of Influenza in Children:a Randomized, Double-blinded, Parallel-controlled Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Academy of Chinese Medical Sciences
    Collaborators
    Children's Hospital of Soochow University, Anhui Provincial Children's Hospital, Qilu Children's Hospital of Shandong University, Tianjin 4th Centre Hospital, Renmin Hospital of Wuhan University, Hebei Maternity&Child Healthcare Hospital, The Second Affiliated Hospital of Jiaxing University, The First Hospital of Hunan University of Chinese Medicine, Affiliated Hospital of Shanxi University of Traditional Chinese Medicine

    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
    The purpose of this study is to evaluate the efficacy, safety of Reduning injection for the treatment of influenza in children.
    Detailed Description
    The clinical efficacy of Traditional Chinese Medicine(TCM) injection was verified by evaluating the efficacy and safety of Reduning injection in the treatment of influenza in children, so as to provide more therapeutic programs for the treatment of influenza in children and provide clinical research evidence for clinical medication.In this study, a parallel control, randomized, double-blind,multi-center trial will be used to design the optimal efficacy of positive drugs.The time of body temperature that return normal was taken as the main therapeutic index.According to the formula of mean superiority test,the number of sample was calculated to 240 cases, with 120 cases in each experimental group and control group.The experimental group was treated with Reduning injection and Oseltamivir phosphate granule simulants, while the control group was treated with Oseltamivir phosphate granules and Reduning injection simulants .Each group will be treated for 5 days.Primary outcome measure this study was mainly from one dimension:Time of temperature recovery.Secondary outcome measures include the time when the fever begins to subside,the time of disease to alleviate,the degree of disease remission,disappearance rate of individual symptoms, etc.Before and after treatment,the temperature of each group was observed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza in Children
    Keywords
    Reduning injection, efficacy and safety, time of temperature recovery, randomized, double blind, parallel control, multi-center clinical study

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Reduning injection +Oseltamivir phosphate granule simulants
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Oseltamivir phosphate granules+ Reduning injection simulants
    Intervention Type
    Drug
    Intervention Name(s)
    Reduning injection
    Other Intervention Name(s)
    Oseltamivir phosphate granule simulants
    Intervention Description
    Reduning injection: 2≤Age≤5,0.5ml/kg/day,<10ml/day+5％GS/0.9％NS 50～100ml,iv drip 30～40gtt/min qd*5; 6≤Age≤10,10ml/day+5％GS/0.9％NS 100～200ml,iv drip 30～60gtt/min qd*5; 11≤Age≤13,15ml/day+5％GS/0.9％NS 200～250ml,iv drip 30～60gtt/min qd*5; Age=14,20ml/day+5％GS/0.9％NS 250ml,iv drip 30～60gtt/min qd*5. Oseltamivir phosphate granules simulants: Weight≤15kg,30mg,po,bid*5; 15<Weight≤23kg,45mg,po,bid*5; 23<Weight≤40kg,60mg,po,bid*5; Weight>40kg,75mg,po,bid*5.
    Intervention Type
    Drug
    Intervention Name(s)
    Oseltamivir phosphate granules
    Other Intervention Name(s)
    Reduning injection simulants
    Intervention Description
    Oseltamivir phosphate granules: Weight≤15kg,30mg,po,bid*5; 15<Weight≤23kg,45mg,po,bid*5; 23<Weight≤40kg,60mg,po,bid*5; Weight>40kg,75mg,po,bid*5. +Reduning injection simulants: 2≤Age≤5,0.5ml/kg/day,<10ml/day+5％GS/0.9％NS 50～100ml,iv drip 30～40gtt/min qd*5; 6≤Age≤10,10ml/day+5％GS/0.9％NS 100～200ml,iv drip 30～60gtt/min qd*5; 11≤Age≤13,15ml/day+5％GS/0.9％NS 200～250ml,iv drip 30～60gtt/min qd*5; Age=14,20ml/day+5％GS/0.9％NS 250ml,iv drip 30～60gtt/min qd*5.
    Primary Outcome Measure Information:
    Title
    The time of temperature recovery.
    Description
    The patients who suffered from influenza were observed their time of temperature recovery .After the first use of the drug,record the time that the patient's temperature dropped to < 37.3℃.The time required for no recurrence within 24 hours.It was the point that evaluated the end of the treatment.
    Time Frame
    If the subject's temperature is less than 37.3℃ and it isn't maintained rise again for 24 hours within 5 days.
    Secondary Outcome Measure Information:
    Title
    The time when the fever begins to subside
    Description
    The time required for the first drop of body temperature to reach or exceed 0.5℃.
    Time Frame
    End of day 5.
    Title
    The time of disease to alleviate
    Description
    The symptom score of each symptom after treatment is 0 or mild and lasts for more than 24 hours.The symptom score is recorded daily.
    Time Frame
    End of day 5.
    Title
    The degree of disease remission
    Description
    According to the"clinical symptom record table", all symptoms were scored.Daily records were recorded to calculate the decrease scores of the total daily symptom score each day.The median time was plotted to calculate Area Under the Curve(AUC) to represent the degree of symptom relief.
    Time Frame
    End of day 5.
    Title
    The disappearance rate of individual symptoms
    Description
    After medication,patients were asked to evaluate the presence or disappearance of each symptoms (such as fever, headache, body pain, fatigue, pharynx pain, nasal congestion, runny nose, sweating, thirst, cough) of the Influenza.
    Time Frame
    End of day 5.
    Title
    The rate of negative conversion of Influenza viral
    Description
    The baseline and the end point of treatment were tested for influenza virus in pharyngeal swab.
    Time Frame
    End of day 5.
    Title
    The number of antipyretic and analgesic drugs used
    Description
    Evaluate the number of combined antipyretic and analgesic drugs used after medication.
    Time Frame
    End of day 5.
    Title
    The incidence of severe/complications of influenza
    Description
    As the end point of the test,collect data of each participants and calculate the incidence rate of severe/complications of influenza.
    Time Frame
    End of day 5.
    Title
    Frequency of antipyretic and analgesic drugs used
    Description
    Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.
    Time Frame
    End of day 5.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: With clinical manifestations of influenza.A rapid detection for virus antigen of influenza result is positive. The patients were suffered from influenza within 48 hours. Subjects aged 2 ~14 years old. Before inclusion into the study, The patient's temperature was over 38 ℃. The guardian agreed to participate in this project and signed the informed consent.Patients aged 8 years old or above with their own wishes must be respected. Exclusion Criteria: Patients with severe or critical illness of influenza. Patients with pneumonia, combined pharyngeal membrane fever, herpetic pharyngitis, suppurative tonsillitis and other diseases. Patients were diagnosed with mycoplasma infection with pharyngeal swab positive or meet the conditions of bacterial infection:White Blood Count(WBC) exceeded 20% of the upper limit of normal range, accompanied by neutrophils increased and serum PCT≥2ug/L, etc. Serum creatinine(SCR) exceeds the upper limit of normal range.Alanine Aminotransferase(ALT) and Aspartate Aminotransferase(AST) exceeded the normal range by more than 2 times. Patients with severe malnutrition, rickets and severe primary diseases of heart, brain, liver, kidney and hematopoietic system. Patients with immunodeficiency or taking glucocorticoid.Patients take other immunosuppressive drugs within the last week. Before be included,patient was taken Oseltamivir or traditional Chinese medicine was used to clear away heat and toxic material within 24 hours. Severely infected persons who must be treated with other antiviral drugs. Allergic to the Reduning injection or Oseltamivir phosphate granules. According to the judgment of the researcher, the patients can cause loss of follow-up should be excluded,such as patients with unstable living environment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanming Xie, BA
    Phone
    86-13911112416
    Email
    ktzu2018@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lianxin Wang, Doctor
    Phone
    86-13521781839
    Email
    wlxing@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanming Xie, Study Principal Investigator
    Organizational Affiliation
    Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Study of Reduning Injection for the Treatment of Influenza in Children

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