A Multiple Center, Randomized Controlled, Double-blinded and Double-dummy Trial of Shuangjie Capsule (Piece) in the Treatment of the Acute Upper Respiratory Tract Infection (the Syndrome of Heat Attacking the Lung and Weifen)_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Lei ¹ , ZHANG Ruiming ² , ZHAO Yanling ³ , FENG Guoxiang ⁴ , PAN Dingju ⁵ , HUANG Xiyuan ⁶ , MAO Bing ¹ , WANG Gang ¹ , CHANG Jing ¹ , ZHANG Ying ¹ , WAN Meihua ¹ , GUO Jia ¹ , CHEN Yan ² ,  LI Tingqian ²

Corresponding author：

LI Tingqian, Email: litingqian@163.com

Keywords：

Shuangjie Capsule; Shuangjie Piece; Acute upper respiratory tract infection; Fengwen syndrome; Randomized controlled trial

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Objective 　To assess the effectiveness and safety of Shuangjie Capsule (Piece) in the treatment of acute upper respiratory tract infection.
Methods 　The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A (n=330, treated with Shuangjie Capsule 3 pieces tid), treatment group B (n=330, treated with Shuangjie Piece 3 pieces tid) and the control group (n=110, treated with Chaihuang Piece 3 pieces tid). The therapeutic course for three groups was 5 days.
Results 　Among 770 included patients, 724 and 718 were screened for intention to treat (ITT) and per-protocol population set (PPS) analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% (ITT) and 84.69% (PPS) respectively, and effective rate were 98.39% (ITT) and 99.02% (PPS) respectively; in treatment group B, the markedly effective rate were 83.28% (ITT) and 83.22% (PPS) respectively, and effective rate were 99.04% (ITT) and 99.03% (PPS) respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group (P lt;0.05). For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% (ITT) and 85.02% (PPS), and effective rate were 98.07% (ITT) and 98.70% (PPS); in treatment group B, the markedly effective rate were 83.92% (ITT) and 83.87% (PPS), and effective rate were 99.36% (ITT) and 99.35% (PPS); while in the control group the markedly effective rate were 74.51% (ITT) and 75.24% (PPS), and effective rate was 98.04% (ITT) and 98.02% (PPS). It also showed a statistical significance between treatment and control group (P lt;0.05). ITT and PP analysis have the same results. No major adverse effect was found in the observation.
Conclusion　 Shuangjie Capsule (Piece) shows a definite effect with no obvious toxic-adverse effects.

Citation： WANG Lei,ZHANG Ruiming,ZHAO Yanling,FENG Guoxiang,PAN Dingju,HUANG Xiyuan,MAO Bing,WANG Gang,CHANG Jing,ZHANG Ying,WAN Meihua,GUO Jia,CHEN Yan,LI Tingqian. A Multiple Center, Randomized Controlled, Double-blinded and Double-dummy Trial of Shuangjie Capsule (Piece) in the Treatment of the Acute Upper Respiratory Tract Infection (the Syndrome of Heat Attacking the Lung and Weifen). Chinese Journal of Evidence-Based Medicine, 2006, 06(3): 162-170. doi: Copy

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1. 四川大学华西医院国家药品临床研究基地 (中药). 双解胶囊Ⅱ期临床试验总结报告 (内部资料), 2004; 5.
2. 叶任高, 主编. 内科学. 第5版. 北京: 人民卫生出版社; 11-13.
3. 郑筱萸主编 .中药新药临床研究指导原则 (试行); 58-60.
4. 刘玉秀, 姚晨, 陈峰, 等. 临床非劣效性/等效性评价的统计学方法. 中国临床药理学与治疗学, 2000; 5(4): 344-349.
5. 国家食品药品监督管理局. 中药新药研究的技术要求; 34-37.
6. 孙丽霞, 黄敬孚. 呼吸道病毒检测与临床意义. 中国医学工程, 2005; 13(3): 325-326.
7. 化学药物和生物制品临床试验的生物统计学技术指导原则 (第二稿). 2004; 21.
8. 李芳, 李建北, 张东明. 柴胡的药理研究进展. 时珍国医国药, 2004;15(2): 120-121.
9. 叶晓平, 宋纯清. 柴胡皂苷药理研究进展. 中草药, 2004; 35(12): 1434-1435.
10. 迟戈夫, 丁丽, 常丽敏. 国内黄芩药理研究进展. 内蒙古民族大学学报(自然科学版), 2005; 20(2): 207-209.
11. 李霞, 于庆海, 艾明, 等. 人工培植牛黄抗炎作用及其机制的初步探讨. 沈阳药科大学学报, 2000; 17(6): 431-433.
12. 顾克显, 郑家润, 高纪伟, 等. 雷醇内酯的抗炎作用. 中国药理学通报, 1994; 10(1): 54-57.
13. 宋民宪, 郭维加, 主编. 新编国家中成药. 北京: 人民卫生出版社, 2002; 74.
14. Kirkpatrick GL. The common cold. Prim Care. 1996; 23: 657-675.
15. Mossad SB. Treatment of the common cold. BMJ. 1998; 317: 33-36.
16. National Base for Drug Clinical Trials (traditional Chinese medicine) in west china hospital of Sichuan University. The report of phase Ⅱclinical trial of Shuangjie Capsule (internal data), 2004; 5.
17. Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001; 285(15): 1987-1991.
18. Ye RG, edit. Internal Medicine. 5th eds. Beijing: People’s Medical Publishing House; 11-13.
19. Zheng XY, Edit. The principle of clinical research for new drug of traditional Chinese medicine; 58-60.
20. Liu YX, Yao C, Chen F, et al. Statistical methods of noninferiority/equivalence trials. Chin J Clin Pharmacol Ther, 2000; 5(4): 344-349.
21. State Drug and Food Administration. Technology rules about new drug of traditional Chinese medicine; 34-37.
22. Sun LX, Huang JF. The detection of virus in respiratory tract. China medical engineering, 2005; 13(3): 325-326.
23. The principle of statistical technology about chemical drugs and biologic drugs. 2004; 21.
24. Tyrrell DA, Cohen S, Schlarb JE. Signs and symptoms in common colds. Epidemiol Infect, 1993; 111: 143-156.
25. Gwaltney JM Jr. Rhinovirus infection of the normal human airway. Am J Respir Crit Care Med. 1995; 152(pt 2): S36-S39.
26. Li F, Li JB, Zhang DM. The pharmacological advance about Chaihu. Lishizhen Medical and Material Medical Research, 2004; 15(2): 120-121.
27. Ye XP, Song CQ. The pharmacological advance about Chaihu saponins. Chinese Traditional and Herb Drugs, 2004; 35(12): 1434-1435.
28. Chi GF, Ding L, Chang LM. The Present Domestic Pharmacological Advance on Scutellaria Baicalensis. Journal of Inner Mongolia University for Nationalities, 2005; 20(2): 207-209.
29. Li X, Yu QH, Ai M, et al. The primary research on pathology of anti-inflammation of artificial cultivated Calcul bovi. Journal of Shenyang Pharmaceutical University, 2000; 17(6): 431-433.
30. Gu KX, Zheng JR, GAO JW, et al. The antiinflammatory of triptolidenol activities. Chinese Pharmacological Bulletin, 1994; 10(1): 54-57.
31. Song MX, Guo WJ, Edit. State Chinese Traditional Patent Medicine. Beijing: People’s Medical Publishing House, 2002; 74.

Chinese Journal of Evidence-Based Medicine

A Multiple Center, Randomized Controlled, Double-blinded and Double-dummy Trial of Shuangjie Capsule (Piece) in the Treatment of the Acute Upper Respiratory Tract Infection (the Syndrome of Heat Attacking the Lung and Weifen)

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