Common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of most common type based on traditional Uighur medicine (TUM) syndrome differentiation, which is widely used in Central Asia. This study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi Granules in treating CCHS.
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. A total of 240 patients will be recruited from 5 centers across China and randomly assigned to the high-dose group, low-dose group or placebo control group in a 1:1:1 ratio. All subjects will receive test drugs twice daily for 3 days. The primary outcome is the time to fever relief. Secondary outcomes include the time to fever clearance, duration of primary symptoms and each symptom, change in TUM symptom score.
This is the first placebo-controlled randomized clinical trial for a Uighur medicine in treating common cold. It will provide robust evidence on the efficacy and safety of Binafuxi Granules in the treatment of CCHS.
The registration number is ChiCTR-IIR-17013379, which was assigned by the Chinese Clinical Trial Registry on 14 November 2017.