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Keke Tablets in the treatment of chronic bronchitis: a multicenter randomized controlled clinical trial
Author(s): LIN Lin, WANG Qi, LI Su-yun, WANG Zhen, HUANG He-qing, MAO Bing, XU Yan-ling, CHENG Jin-le, LIANG Yan-ling, The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan College of Traditional Chinese Medicine, Zhejiang Provincial Hospital of Traditional Chinese Medicine, The Second People’s Hospital of Fujian Province, West China Hospital, Sichuan University, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Zhongshan Zhongzhi Pharmaceutical Group Co., Ltd.
Pages: 2636-
2638
Year: 2015
Issue:
7
Journal: China Journal of Traditional Chinese Medicine and Pharmacy
Keyword: Keke Tablets; Chronic bronchitis; Wind-cold syndrome; Wind-cold complicated with phlegm-dampness; Cough;
Abstract: Objective: To investigate the therapeutic effect and safety of Keke Tablets for chronic bronchitis with windcold syndrome or wind-cold complicated with phlegm-dampness. Methods: A multicenter trial of stratified block randomization, double-blind, double-mimic, positive-medicine parallel-control was carried out in chronic bronchitis patients. A total of 240 patients were randomized into an observation group and a control group in the proportion of 3∶1. The observation group was given Keke Tablets and sham Tongxuan Lifei Tablets, while the control group was given Tongxuan Lifei Tablets and sham keke tablets orally, lasting for 7 days. The scores of cough, visual analogue scale(VAS) and traditional Chinese medical syndrome were compared before and after treatment. The relief and recurrence of cough were observed, and the safety was also monitored during the treatment. Results: A total of 225 qualified patients were enrolled, 169 cases were in the observation group and 56 cases in the control group. After treatment, the scores of cough and VAS were improved in both groups(P<0.01), compared with those before treatment), but the differences between the two groups were insignificant. The total effective rate of efficacy of traditional Chinese medical syndrome was 94.67%, the average time for cough relief was(4.03±2.14)d, the remission rate of cough was 72.19%, and recurrence rate of cough was 3.55% in the observation group. Compared with the control group, the difference was insignificant. No adverse reaction occurred in the observation group or the control group. Conclusion: Keke Tablets showed certain clinical efficacy and safety for treatment of chronic bronchitis with wind-cold syndrome or wind-cold complicated with phlegm-dampness.
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