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

Phase 4

• Conditions: Influenza in Children
• Interventions: Drug: Reduning injection; Drug: Oseltamivir phosphate granules

• Registration Number: NCT04183725
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-28
• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Posted: 2019-12-03
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Reduning injection	Reduning injection +Oseltamivir phosphate granule simulants
Control group	Oseltamivir phosphate granules	Oseltamivir phosphate granules+ Reduning injection simulants

Primary Outcome Measures

Name	Time	Method
The time of temperature recovery.	If the subject's temperature is less than 37.3℃ and it isn't maintained rise again for 24 hours within 5 days.	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

Name	Time	Method
The time when the fever begins to subside	End of day 5.	The time required for the first drop of body temperature to reach or exceed 0.5℃.
Frequency of antipyretic and analgesic drugs used	End of day 5.	Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.
The time of disease to alleviate	End of day 5.	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	End of day 5.	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	End of day 5.	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 number of antipyretic and analgesic drugs used	End of day 5.	Evaluate the number of combined antipyretic and analgesic drugs used after medication.
The incidence of severe/complications of influenza	End of day 5.	As the end point of the test,collect data of each participants and calculate the incidence rate of severe/complications of influenza.
The rate of negative conversion of Influenza viral	End of day 5.	The baseline and the end point of treatment were tested for influenza virus in pharyngeal swab.