Abstract
BackgroundThe common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS).Methods/designThis is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms’ clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores.DiscussionThis trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM.Trial registrationChinese Clinical Trial Registry, ChiCTR-IPR-15006504. Registered on 4 June 2015.
Highlights
The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract
This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA)
The protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on traditional Chinese medicine (TCM)
Summary
No proven effective drugs or methods in clinical practice can cure the common cold. Evidence-based efficacy and safety data on Chinese herbs are limited, because the studies have used small sample sizes or are of poor quality [26]. It is widely recognized that a randomized placebocontrolled trial is the gold standard to evaluate the safety and efficacy of a drug or treatment method. The study is expected to provide high-quality evidence in evaluating the efficacy and safety of LJGMC in treating CCWHS, and it may help to optimize the dose for the phase III clinical trial based on the four parallel set groups. The protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. Additional file 1: SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents.
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