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| Phase III clinical study on the treatment of menopause syndrome by Gengshu particles discriminated as deficiency of liver-yin and kidney-yin |
| Hits 1569 Download times 1899 Received:April 23, 2015 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2015.09.07 |
| Key Words
Gengshu particle;menopause syndrome;clinical trial |
| Author Name | Affiliation | | YAN Ying | Department of Gynecology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | WANG Hui-jin | Department of Gynecology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | WANG Hong-zhen | Wantong Pharmacy Group Corporation, Tonghua 134000, China | | CHEN Li-huai | Department of Gynecology, The Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun 130021, China | | SHI Ling | Department of Gynecology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110000, China | | SONG Dian-rong | Department of Gynecology, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China | | ZHAO Rui-hua | Department of Gynecology, Guanganmen Hospital of Chinese Academy of Traditional Chinese Medicine, Beijing 100053, China | | WEI Shao-bin | Department of Gynecology, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, China | | CHEN Ying | Department of Gynecology, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China | | ZHONG Cheng-liang | Department of Gynecology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | ZHANG Li-wei | Wantong Pharmacy Group Corporation, Tonghua 134000, China | | LI Ying | Wantong Pharmacy Group Corporation, Tonghua 134000, China | | BI Fu-xi | Department of Gynecology, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China |
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| Abstract
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| [Objective] Regarding gengnianan tablets as positive control drug,to confirm the effect of gengshu particles for of menopausal syndrome of liver and kidney yin deficiency. [Methods] The test used the method of stratified random, double-blind, positive drug parallel controlled, multi center, we adopt 480 patients of menopausal syndrome and divided into 2 groups, 360 for the test group, in which 0 cases were excluded, 10 were lost to follow up; 120 were in the control group, in which 1 were excluded, 9 were lost to follow up. The patients of test group oral Gengshu particles analog with simulation of Gengnianan tablets, The patients of control group oral Gengnianan tablets along with simulation of Gengshu particles. The course of treatment was 14 days. [Results] FAS analysis results of the curative effect of disease, the test group total effective was 58.1%, and 38.7% for the control group, there was significant difference. FAS analysis results of the efficacy of traditional Chinese medicine(TCM) syndrome. The clinical cure rate of the test group was 14.2%, and of all the total effective rate was 52.5%, total effective rate was 95.8%. The positive control group, the cure rate was 1.7%. The total effective rate was 24.4%, and of all the total efficiency of 84%. The differences were statistically significant (P=0.000). Non inferiority test results show that: the efficacy of the test group is non inferior to the control group. [Conclusion] Gengshu particles are more safe and effective in the treatment of menopause syndrome. |
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