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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Affiliated Hospital of Shanxi University of Traditional Chinese Medicine; Anhui Provincial Children's Hospital; Children's Hospital Of Soochow University; Hebei Maternity&Child Healthcare Hospital; Qilu Childre's Hospital of Shandong University; Qilu Children's Hospital of Shandong University; Renmin Hospital of Wuhan University; Second Affiliated Hospital of Jiaxing University; The First Hospital of Hunan University of Chinese Medicine; The Second Affiliated Hospital of Jiaxing University; Tianjin 4th Centre Hospital
• Treatments: Oseltamivir

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.