|
 Services |
|
|
 |
Subscribe |
|
|
|
|
|
|
Response |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Information
For |
|
|
|
|
|
|
|
|
| About
JCIM |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Journal of Chinese Integrative Medicine: 2005; 3(3): 191-194
DOI: 10.3736/jcim20050307 |
|
| Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study |
| 1. | LU Jin-Gen (Shanghai Municipal Clinical Medicine Center for Chinese Traditional Surgery, Shanghai 200032, China E-mail: lujingen@longhua.net) | | 2. | PAN Yi-Bin (Shanghai Municipal Clinical Medicine Center for Chinese Traditional Surgery, Shanghai 200032, China ) | | 3. | CAO Yong-Qing (Shanghai Municipal Clinical Medicine Center for Chinese Traditional Surgery, Shanghai 200032, China ) | | 4. | YANG Wei (Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200021 ) | | 5. | ZHANG Xin-Lin (Department of Anorectal Surgery, Shanghai Hospital of Traditonal Chinese Medicine, Shanghai 200071, China ) |
|
|
Objectives: To assess the efficacy of Fuhuang Tablets in treating internal hemorrhoid hemorrhage and discussing the design and quality control of clinical trials of traditional Chinese medicine.
Methods: According to two-center, randomized, blinded and controlled study, 144 patients with internal hemorrhoids were divided into 2 groups. Seventy-two patients were treated with Fuhuang Tablets (4 tablets t.i.d. per os) and the other 72 patients were treated with Zhining Tablets (4 tablets t.i.d. per os). Symptoms and signs of the patients were recorded and evaluated at the third and seventh day of treatment respectively.
Results: At the third day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 58.57% and 27.78% respectively, with statistic difference between the two groups (P<0.05). At the seventh day of treatment, the overall response rates of Fuhuang Tablets-treated group and Zhining Tablets-treated group were 91.43% and 81.94% respectively, with no statistic difference between the two groups. The laboratory test results and life signs of the 144 patients were normal before and after the treatment.
Conclusion: Fuhuang Tablets are effective and safe in treating internal hemorrhoid hemorrhage. |
|
| Welcome to JCIM! You are the number
3255
reader of this article! |
|
| Download Article: |
| [Full Text] [PDF] [Chinese] [Previous] [Next] [This Issue] |
|
| Please cite this article as: |
| Lu JG, Pan YB, Cao YQ, Yang W, Zhang L. Discussion on design and quality control of clinical trials of traditional Chinese medicine on the basis of Fuhuang Tablets clinical study. J Chin Integr Med / Zhong Xi Yi Jie He Xue Bao. 2005; 3(3): 191-194. |
|
| References:
|
| 1 | 中华外科协会肛肠分会. 痔诊治暂行标准[J].中华外科杂志, 2000, 38(12): 891. . |
| 2 | 郑筱萸. 中药新药临床研究指导原则[M]. 第1版. 北京: 中国医药科技出版社, 2002. 285. . |
| 3 | 上海市卫生局. 上海市中医病症诊疗常规[M]. 第1版. 上海: 上海中医药大学出版社, 1998. 229. . |
| 4 | 国家食品药品监督管理局. 药物临床试验质量管理规范 [S] . 2003 . 9 . |
|
|
|
|
|
|