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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety of Reduning injection for the treatment of influenza in children.

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Detailed Description

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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.

Conditions

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Influenza in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group

Reduning injection +Oseltamivir phosphate granule simulants

Group Type EXPERIMENTAL

Reduning injection

Intervention Type DRUG

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.

Control group

Oseltamivir phosphate granules+ Reduning injection simulants

Group Type ACTIVE_COMPARATOR

Oseltamivir phosphate granules

Intervention Type DRUG

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.

Interventions

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Reduning injection

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

Oseltamivir phosphate granules

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.

Intervention Type DRUG

Other Intervention Names

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Oseltamivir phosphate granule simulants Reduning injection simulants

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No