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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002740
Enrollment
Unknown
Registered
2019-11-07
Start date
2019-11-15
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
complete antifebrile time;

Secondary

MeasureTime frame
Dosage of acetaminophen sustained release agent;TCM symptom score;Remission time for other important clinical symptoms (headache, fatigue, sore throat, coughing, nasal congestion, chills, muscle or joint pain);Antipyretic effect time;AUC disappearance time;

Countries

China

Contacts

Public ContactJiangtao Lin

China-Japan Friendship Hospital

jiangtao_l@263.net+86 010-84206187

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026