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Clinical Trials/ITMCTR1900002740
ITMCTR1900002740
Not yet recruiting
Phase 4

A randomized, double-blind, positive-drug, parallel-controlled multi-center clinical trial of the efficacy and safety of Chaishi Tuire granules for influenza.(RADICAL)

China-Japan Friendship Hospital0 sitesTBD
ConditionsInfluenza

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Influenza
Sponsor
China-Japan Friendship Hospital
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • 1\. Conforms to the western medical diagnosis and treatment standard of influenza (revised version 2018\);
  • 2\. Meet the standard of syndrome differentiation of wind\-heat syndrome;
  • 3\. Between 18 and 75 years old;
  • 4\. Duration within 48 hours and less, axillary temperature \>\= 38 degree C;
  • 5\. Rapid virus antigen test results were positive;
  • 6\. Agree and sign informed consent.

Exclusion Criteria

  • 1\. Within 12 hours before enrollment, receive relevant drug treatment, such as antibiotics, antiviral drugs, hormone drugs, antipyretic and analgesic drugs, and drugs for treating influenza indicated in the instruction manual;
  • 2\. Complications such as sinusitis, acute bronchitis and pneumonia;
  • 3\. Patients with the following serious lung diseases (such as asthma, chronic bronchitis, tuberculosis, etc.), primary cardiovascular diseases, liver diseases, kidney diseases, hematological diseases, or other serious diseases that affect their survival;
  • 4\. Influenza vaccine was given within 12 months before the trial began;
  • 5\. The upper limit of ALT and AST \> normal value is 1\.5 times, and the blood Cr exceeds the upper limit of normal value;
  • 6\. Immunodeficiency or immunosuppression, such as AIDS, malignant tumors, organ transplantation, or taking immunosuppressive drugs or glucocorticoids within the last 3 months;
  • 7\. Allergic constitution (allergic to more than 2 kinds of substances), or allergic to the components of this preparation or the control drug;
  • 8\. Pregnant, pregnant or lactating women;
  • 9\. Have participated in other clinical trials within the past month;
  • 10\. Patients who are unable to cooperate or who are mentally ill are considered unfit to participate in this clinical trial.

Outcomes

Primary Outcomes

Not specified

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