Efficacy and safety of herbal medicine (Binafuxi granules) for the common cold with fever: A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial.

ABSTRACT:

Background

Binafuxi granules are a traditional Uighur medicine (TUM) for treating the common cold with fever. However, high-quality clinical studies supporting its efficacy and safety are lacking.

Methods

In this multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial, patients with common cold and fever were randomly assigned to a high-dose group, low-dose group, and placebo group in a 1:1:1 ratio. Outcomes were time to fever relief, time to fever clearance, proportion of afebrile patients, time to symptom disappearance, rate of symptom disappearance, effective rate, emergency drug usage and safety assessment.

Results

A total of 235 patients were recruited. Of these, 234 were included in the full analysis set (FAS), and 217 were included in

SUBMITTER: Liu X 

PROVIDER: S-EPMC10285547 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature