Influenza in ChildrenPhase 4NCT04183725
Clinical Study of Reduning Injection for the Treatment of Influenza in Children
A Phase 4 study testing Reduning injection and Oseltamivir phosphate granules in people with Influenza in Children, run by China Academy of Chinese Medical Sciences.
Trial summary
The purpose of this study is to evaluate the efficacy, safety of Reduning injection for the treatment of influenza in children. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Influenza in Children
- What is being tested?
- Reduning injection and Oseltamivir phosphate granules
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza in Children
- Being tested
- Reduning injection, Oseltamivir phosphate granules
- Keywords
- Reduning injection, efficacy and safety, time of temperature recovery, randomized, double blind, parallel control, multi-center clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduning injectionDrug
Also called Oseltamivir phosphate granule simulants
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.
Oseltamivir phosphate granulesDrug
Also called Reduning injection simulants
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Reduning injection +Oseltamivir phosphate granule simulants Receives: Drug: Reduning injection |
| Control group | Active comparator | Oseltamivir phosphate granules+ Reduning injection simulants Receives: Drug: Oseltamivir phosphate granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The time required for the first drop of body temperature to reach or exceed 0.5℃.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of day 5.
The number of antipyretic and analgesic drugs used
Evaluate the number of combined antipyretic and analgesic drugs used after medication.
Measured: 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.
Measured: End of day 5.
Frequency of antipyretic and analgesic drugs used
Evaluate the frequency of combined antipyretic and analgesic drugs used after medication.
Measured: End of day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- 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 Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, Study Principal Investigator, Study chair, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183725
- Sponsor's protocol ID
- Reduning injection
- Status last verified
- Dec 2019
- First submitted
- 22 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37474974
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduning Injection for the Treatment of Influenza in Children:a Randomized, Double-blinded, Parallel-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04183725
- Acronym / sponsor ID
- Reduning injection
- Conditions
- Influenza in Children
- Keywords
- Reduning injection, efficacy and safety, time of temperature recovery, randomized, double blind, parallel control, multi-center clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- 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 Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Reduning injectionReduning injection +Oseltamivir phosphate granule simulants |
| Control group | Active comparator | Drug: Oseltamivir phosphate granulesOseltamivir phosphate granules+ Reduning injection simulants |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduning injectionAlso: Oseltamivir phosphate granule simulantsReduning 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. | Drug | Experimental group |
| Oseltamivir phosphate granulesAlso: Reduning injection simulantsOseltamivir 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. | Drug | Control group |
Primary outcome
The time of temperature recovery.
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.
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.
8 secondary outcomes
The time when the fever begins to subside
Time frame: End of day 5.
The time of disease to alleviate
Time frame: End of day 5.
The degree of disease remission
Time frame: End of day 5.
The disappearance rate of individual symptoms
Time frame: End of day 5.
The rate of negative conversion of Influenza viral
Time frame: End of day 5.
The number of antipyretic and analgesic drugs used
Time frame: End of day 5.
The incidence of severe/complications of influenza
Time frame: End of day 5.
Frequency of antipyretic and analgesic drugs used
Time frame: End of day 5.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Derived from this study: PubMed 37474974Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, Study Principal Investigator study chair
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduning injection and Oseltamivir phosphate granules in people with Influenza in Children, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time of temperature recovery. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.