Efficacy and safety of chaishituire granules in influenza treatment: a multi-center, randomized, double-blind, parallel-controlled clinical trial.

OBJECTIVES

Information on the safety and efficacy of chaishituire granules (CSTR) for treating influenza is limited. We evaluated the safety and efficacy of CSTR in shortening the disease and fever course and improving the traditional Chinese medicine (TCM) syndrome score in influenza treatment.

METHODS

This multi-center, randomized, positive-drug, parallel-controlled study involved 17 hospitals across China and 221 patients with influenza aged 14-75 years. These patients met the syndrome differentiation criteria for "Wind-Heat Invading the Wei-Exterior". Patients in the CSTR group received CSTR and oseltamivir phosphate dummy capsules, whereas those in the oseltamivir control group received oseltamivir phosphate capsules and CSTR dummy granules. The primary outcomes were the time to complete remission of fever and the main clinical symptoms. The secondary outcomes were the time to elicit antipyretic effects, acetaminophen use, TCM syndrome score, remission rate of main clinical symptoms, single symptom area under the curve (AUC), and the incidence of complications or severe/critical diseases.

RESULTS

The TCM syndrome score, single symptom AUC, incidence of complications and severe/critical disease, time to complete remission of fever, main clinical symptoms, and initiation of antipyretic effects were evaluated. However, CSTR demonstrated a more rapid action and superior efficacy in alleviating sore throat compared to oseltamivir. The incidence of adverse reactions was similar between the groups.

CONCLUSIONS

CSTR could be an alternative therapy for influenza virus infections.