Abstract
BackgroundThe common cold is a highly prevalent illness with significant impact on society and health care. Common cold with heat syndrome (CCHS) is one of the most common types based on syndrome differentiation by traditional Uighur medicine (TUM), which is widely used in Central Asia. The study is designed to explore the efficacy, safety and optimal therapeutic dosage of Binafuxi granules in treating CCHS.MethodsThis is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five 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 eligible patients 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 and change in TUM symptom score.DiscussionThis is the first placebo-controlled randomized clinical trial of 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.Trial registrationChinese Clinical Trial Registry, ChiCTR-IIR-17013379. Registered on 14 November 2017.
Highlights
The common cold is a highly prevalent illness with significant impact on society and health care
Inclusion criteria The inclusion criteria are as follows: (1) meet the diagnosis of common cold according to Western medicine; (2) meet the diagnosis of Common cold with heat syndrome (CCHS) according to traditional Uighur medicine; (3) fever and body temperature between 38 and 39 °C; (4) symptom presenting within 24 h; (5) age between 18 and 65 years and (6) voluntarily participate and provide signed informed consent
Most of traditional Uighur medicine (TUM) researches have focused on therapy of skin disease, urogenital disease, rheumatism, digestive system and respiratory system disease [24]
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial. Participants (n = 240) will be enrolled from five 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 eligible patients 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 and change in TUM symptom score
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