Abstract
BackgroundAlthough the common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work. In light of its favorable effects of relieving symptoms and minimal side-effects, Traditional Chinese Medicine (TCM) has been widely used to treat the common cold. However, there is a lack of robust evidence to support the clinical utility of such a treatment. This study is designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with the common cold with wind-heat syndrome (CCWHS).Methods/DesignThis is a multicenter, phase IIb, double-blind, placebo-controlled and randomized clinical trial. A total of 240 patients will be recruited, from 5 centers across China and randomly assigned to the high-dose group, medium-dose group, low-dose group or placebo control group in a 1:1:1:1 ratio. All subjects will receive the treatment for 3 to 5 days, followed by a 7-day follow-up period. The primary outcome is the duration of all symptoms. Secondary outcomes include the duration of primary symptoms and each symptom, time to fever relief and time to fever clearance, change in TCM symptom score, and change in Symptom and Sign Score.DiscussionThis trial will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and help to optimize the dose selection for a phase III clinical trial.Trial registrationThe registration number is ChiCTR-TRC-14004255, which was assigned by the Chinese Clinical Trial Registry on 12 February 2014.
Highlights
The common cold is generally mild and self-limiting, it is a leading cause of consultations with doctors and missed days from school and work
Based on Traditional Chinese Medicine (TCM) syndrome differentiation, the common cold can be divided into the windcold, wind-heat or summer-heat dampness syndrome according to its symptoms and TCM signs, such as fever, headache, fatigue, aversion to cold, sneezing, nasal congestion, nasal discharge, nausea, vomiting, tongue proper, tongue coating and condition of pulse [15]
In accordance with the Drug Administration Law of the People’s Republic of China and Good Clinical Practice (GCP) issued by China Food and Drug Administration (CFDA), this phase IIb clinical trial is well-designed to evaluate the efficacy and safety of Gantong Granules compared with placebo in patients with common cold with wind-heat syndrome (CCWHS)
Summary
The common cold is something that one may experience multiple times throughout his or her lifetime. It is widely recognized that the randomized controlled trial is a ‘gold standard’ methodology for evaluating the clinical efficacy and safety of an intervention. Chinese herbs have been widely used to treat the common cold in China and many other countries, the quality of most prior studies was assessed to be generally low due to methodological limitations like inadequate randomization, lack of double blinding, non-placebo control, incomplete outcome data, and so on [21,22]. As far as we know, this study will be the first multicenter, double-blind, placebo-controlled and randomized clinical trial that is designed to treat CCWHS. Based on scientific and objective assessment, this study will provide high-quality evidence on the efficacy and safety of Gantong Granules in treating CCWHS, and may help to optimize the dose selection for a phase III clinical trial.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
