Clinical trial NCT04183725: Clinical Study of Reduning Injection for the Treatment of Influenza in Children
Official title: Reduning Injection for the Treatment of Influenza in Children:a Randomized, Double-blinded, Parallel-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza in Children
Keywords: Reduning injection
efficacy and safety
time of temperature recovery
randomized
double blind
parallel control
multi-center clinical study
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Soochow University
name: Anhui Provincial Children's Hospital
name: Qilu Children's Hospital of Shandong University
name: Tianjin 4th Centre Hospital
name: Renmin Hospital of Wuhan University
name: Hebei Maternity&Child Healthcare Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: Hunan University of Traditional Chinese Medicine
name: Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
First posted: 2019-12-03
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The time of temperature recovery.
timeFrame: 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:
measure: The time when the fever begins to subside
timeFrame: End of day 5.
measure: The time of disease to alleviate
timeFrame: End of day 5.
measure: The degree of disease remission
timeFrame: End of day 5.
measure: The disappearance rate of individual symptoms
timeFrame: End of day 5.
measure: The rate of negative conversion of Influenza viral
timeFrame: End of day 5.
measure: The number of antipyretic and analgesic drugs used
timeFrame: End of day 5.
measure: The incidence of severe/complications of influenza
timeFrame: End of day 5.
measure: Frequency of antipyretic and analgesic drugs used
timeFrame: End of day 5.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, Study Principal Investigator
role: STUDY_CHAIR
References: