Brief Summary

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

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

240

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Dec 2019

Typical duration for phase_4

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

November 22, 2019

Completed

9 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed

Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

November 22, 2019

Last Update Submit

December 3, 2019

Conditions

Influenza in Children

Keywords

Reduning injectionefficacy and safetytime of temperature recoveryrandomizeddouble blindparallel controlmulti-center clinical study

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

The time when the fever begins to subside
End of day 5.
The time of disease to alleviate
End of day 5.
The degree of disease remission
End of day 5.
The disappearance rate of individual symptoms
End of day 5.
The rate of negative conversion of Influenza viral
End of day 5.
+3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Reduning injection +Oseltamivir phosphate granule simulants

Drug: Reduning injection

Control group

ACTIVE COMPARATOR

Oseltamivir phosphate granules+ Reduning injection simulants

Drug: Oseltamivir phosphate granules

Interventions

Reduning injectionDRUG

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.

Also known as: Oseltamivir phosphate granule simulants

Experimental group

Oseltamivir phosphate granulesDRUG

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.

Also known as: Reduning injection simulants

Control group

Eligibility Criteria

Age2 Years - 14 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.
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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

China Academy of Chinese Medical Scienceslead
Children's Hospital of Soochow Universitycollaborator
Anhui Provincial Children's Hospitalcollaborator
Qilu Children's Hospital of Shandong Universitycollaborator
Tianjin 4th Centre Hospitalcollaborator
Renmin Hospital of Wuhan Universitycollaborator
Hebei Maternity&Child Healthcare Hospitalcollaborator
The Second Affiliated Hospital of Jiaxing Universitycollaborator
Hunan University of Traditional Chinese Medicinecollaborator
Affiliated Hospital of Shanxi University of Traditional Chinese Medicinecollaborator

Related Publications (1)

Yang S, Xie YM, Wang LX. RDN for the treatment of influenza in children: a randomized, double-blinded, parallel-controlled clinical trial. BMC Complement Med Ther. 2023 Jul 20;23(1):255. doi: 10.1186/s12906-023-04037-1.
PMID: 37474974DERIVED

MeSH Terms

Interventions

reduning

Study Officials

Yanming Xie, Study Principal Investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
STUDY CHAIR

Central Study Contacts

Yanming Xie, BA

CONTACT

86-13911112416 ktzu2018@163.com

Lianxin Wang, Doctor

CONTACT

86-13521781839 wlxing@126.com

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Deputy director

Study Record Dates

First Submitted

November 22, 2019

First Posted

December 3, 2019

Study Start

December 1, 2019

Primary Completion

June 1, 2021

Study Completion

December 31, 2021

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing: Will not share

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Experimental group

Control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing