Background. Common cold is one of the most frequently occurring illnesses in primary healthcare services and represents\nconsiderable disease burden. Common cold of Qi-deficiency syndrome (CCQDS) is an important but less addressed traditional\nChinese medicine (TCM) pattern. We designed a protocol to explore the efficacy, safety, and optimal dose of Shen Guo Lao Nian\nGranule (SGLNG) for treatingCCQDS.Methods/Design.This is amulticenter, randomized, double-blind, placebo-controlled, phase\nII clinical trial. A total of 240 eligible patients will be recruited fromfive centers. Patients are randomly assigned to high-dose group,\nmiddle-dose group, low-dose group, or control group in a 1 : 1 : 1 : 1 ratio. All drugs are required to be taken 3 times daily for 5 days\nwith a 5-day follow-up period. Primary outcomes are duration of all symptoms, total score reduction on Jackson�s scale, and TCM\nsymptoms scale. Secondary outcomes include every single TCM symptom duration and score reduction, TCM main symptoms\ndisappearance rate, curative effects, and comparison between Jackson�s scale and TCMsymptomscale. Ethics and Trial Registration.\nThis study protocol was approved by the Ethics Committee of Clinical Trials and Biomedicine of West China Hospital of Sichuan\nUniversity (number IRB-2014-12) and registered with the Chinese Clinical Trial Registry (ChiCTR-IPR-15006349).
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