Chaihu Drop-pill in Treatment of Common Cold: A Multi-center and Randomized Controlled Trial_West China Medical Journal

Authors：

 CHANGJing ¹ , TANGFang ² , YANFeng-jie ³ , CAIHong-yan ⁴ , QIAOShi-ju ⁵ , XIONGXu-dong ⁶ , XUEHan-rong ⁷ , CHENZhi-bin ⁸ ,  MAOBing ¹

1. Department of Combination of Traditional Chinese Medicine and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
2. Department of Respiratory Diseases, Tianjin Medical University General Hospital, Tianjin 300052, P. R. China;
3. Department of Respiratory Diseases, the Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, Jilin 130021, P. R. China;
4. Department of Respiratory Diseases, the Integrated Medicine Hospital of Jilin Province, Changchun, Jilin 130021, P. R. China;
5. Department of Respiratory Diseases, the Second Affiliated Hospital to Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning 110034, P. R. China;
6. Department of Respiratory Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China;
7. Department of Respiratory Diseases, the Affiliated Hospital to Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi 330006, P. R. China;
8. Department of Respiratory Diseases, Fujian Institute of Traditional Chinese Medicine, Fuzhou, Fujian 350003, P. R. China;

Corresponding author：

MAOBing, Email: maobing@medmail.com.cn

Keywords：

Herbal preparations; Randomized controlled trial; Common cold; Wind-heat syndrome; Traditional Chinese medicine

DOI：

10.7507/1002-0179.20150185

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Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the safety and efficacy of Chaihu drop-pill in the treatment of common cold (wind-heat syndrome). Methods A multi-center, double blind, double dummy, randomized controlled trial was conducted. A total of 479 patients with common cold (wind-heat syndrome) diagnosed between February and August, 2011, were randomly divided into two groups:the trial group (n=359) and the control group (n=120). The trial group received Chaihu drop-pill and Yinchai granule analogue three times a day, while the control group received Yinchai granule and Chaihu drop-pill analogue. The therapeutic courses of both groups were 3 days. Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment. Furthermore, blood, urine and stool test, hepatorenal function test and electrocardiogram were also carried out before and after treatment. Results After treatment, the healing rates of the trial group and the control group were 32.4%, 20.2% (for full analysis set) and 32.6%, 20.5% (for per protocol set), and the overall response rates were 96.3%, 87.4% (for full analysis set) and 96.5%, 87.2% (for per protocol set). There were significant differences between the two groups (P<0.01). No adverse effects were found in the trial. Conclusion Chaihu drop-pill is effective and safe in the treatment of common cold (wind-heat syndrome).

Citation： CHANGJing, TANGFang, YANFeng-jie, CAIHong-yan, QIAOShi-ju, XIONGXu-dong, XUEHan-rong, CHENZhi-bin, MAOBing. Chaihu Drop-pill in Treatment of Common Cold: A Multi-center and Randomized Controlled Trial. West China Medical Journal, 2015, 30(4): 635-639. doi: 10.7507/1002-0179.20150185 Copy

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1. 李璐易, 姚宝莹, 刘晓慧, 等. 京沪两地看病调查[J]. 首都医药, 2010, 17(5):13-18.
2. 殷凯生. 普通感冒的流行病学与疾病负担[J]. 中华内科杂志, 2012, 51(4):259-260.
3. 中国医师协会呼吸医师分会, 中国医师协会急诊医师分会. 普通感冒规范诊治的专家共识[J]. 中华内科杂志, 2012, 51(4):330-333.
4. 郭汝宁, 康敏, 郑慧贞. 2006年广州市居民普通感冒发病及就诊行为分析[J]. 华南预防医学, 2008, 34(4):46-48, 52.
5. 刘国梁, 林江涛, 刘关键, 等. 门诊普通感冒患者对普通感冒认知的调查[J]. 中华内科杂志, 2012, 51(4):262-265.
6. 张文斌, 蒋红丽, 周维, 等. 中药治疗急性上呼吸道感染随机对照试验的系统评价[J]. 中西医结合学报, 2009, 7(8):706-716.
7. 国家食品药品监督管理局. 中药品种保护指导原则[EB/OL]. (2010-07-01)[2014-11-01]. http://www.zybh.gov.cn/d?xh=140891.
8. 陆再英, 钟南山. 内科学[M]. 7版. 北京:人民卫生出版社, 2008:11.
9. 郑筱萸. 中药新药临床研究指导原则:试行[M]. 北京:中国医药科技出版社, 2002:58-60.
10. 国家药品监督管理局. 《药物临床试验质量管理规范》(局令第3号)[EB/OL]. (2003-08-06)[2014-11-01]. http://www.sda.gov.cn/WS01/CL0053/24473.html.
11. 黄伟, 孙蓉. 柴胡皂苷类成分化学与药理和毒理作用研究进展[J]. 中药药理与临床, 2010, 26(3):71-74.
12. 苏伟, 陈信义, 李冬云, 等. 柴胡滴丸治疗风热感冒临床疗效观察[J]. 北京中医药大学学报, 1998, 21(4):56-57.
13. 吴迺峰, 郭治昕, 王俊显, 等. 柴胡滴丸治疗感冒的临床研究[J]. 中国医院导刊, 2000, 2(3):37-39.

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West China Medical Journal

Chaihu Drop-pill in Treatment of Common Cold: A Multi-center and Randomized Controlled Trial

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