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Fig. 1 | Trials

Fig. 1

From: Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: study protocol of a randomized, double-blind, placebo-controlled trial

Fig. 1

Flow chart of the study, a randomized, double-blind, placebo-controlled trial. A total of 100 patients will be recruited and randomly assigned to one of the two treatments group, with 50 in each group. One-hundred COPD patients will be randomly assigned to two treatment groups (SHGBZK treatment, N = 50; placebo treatment, N = 50). The two groups will receive basic treatment for COPD according to the 2017 GOLD Guidelines for Chronic Obstructive Pulmonary Disease. Patients will stick to the treatment they used to take as much as possible and will be given the trial treatment when AECOPD occurs during the study. Both groups will receive a 24-week intervention, and patient status will be assessed at 24 weeks and then 28 weeks after treatment. The outcome measures, including the frequency and duration of acute exacerbation, lung function, TCM symptom score, exercise capacity, and quality of life, will be assessed. Patients need to take medication as directed by the doctor. The use of glucocorticoids, antibiotics, mucolytic agents, and antitussive agents is prohibited during the study except if AECOPD occurs, and oral or external Chinese medicine preparations with the effect of tonifying the spleen and lung are prohibited during the trial period

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