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

Reduning Injection for the Treatment of Influenza in Children:a Randomized, Double-blinded, Parallel-controlled Clinical Study

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

Study Overview

• Status: Unknown
• Conditions: Influenza in Children
• Intervention / Treatment: Drug: Reduning injection; Drug: Oseltamivir phosphate granules

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanming Xie, BA; Phone Number: 86-13911112416; Email: ktzu2018@163.com
• Study Contact Backup: Name: Lianxin Wang, Doctor; Phone Number: 86-13521781839; Email: wlxing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Reduning injection +Oseltamivir phosphate granule simulants	Drug: 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; 1540kg,75mg,po,bid*5.; Other Names: Oseltamivir phosphate granule simulants
Active Comparator: Control group; Oseltamivir phosphate granules+ Reduning injection simulants	Drug: Oseltamivir phosphate granules; Oseltamivir phosphate granules: Weight≤15kg,30mg,po,bid*5; 1540kg,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.; Other Names: Reduning injection simulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
The time when the fever begins to subside	The time required for the first drop of body temperature to reach or exceed 0.5℃.	End of day 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.	End of day 5.
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.	End of day 5.
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.	End of day 5.
The rate of negative conversion of Influenza viral	The baseline and the end point of treatment were tested for influenza virus in pharyngeal swab.	End of day 5.
The number of antipyretic and analgesic drugs used	Evaluate the number of combined antipyretic and analgesic drugs used after medication.	End of day 5.
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.	End of day 5.
Frequency of antipyretic and analgesic drugs used	Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.	End of day 5.

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Renmin Hospital of Wuhan University; Children's Hospital of Soochow University; The Second Affiliated Hospital of Jiaxing University; Qilu Children's Hospital of Shandong University; Tianjin 4th Centre Hospital; The First Hospital of Hunan University of Chinese Medicine; Anhui Provincial Children's Hospital; Hebei Maternity&Child Healthcare Hospital; Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
• Investigators: Study Chair: Yanming Xie, Study Principal Investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 28, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: efficacy and safety; randomized; double blind; parallel control; multi-center clinical study; Reduning injection; time of temperature recovery
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Oseltamivir
• Other Study ID Numbers: Reduning injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No