| Autor: |
Ling Qu, Xiao-chun Liang, Guo-qing Tian, Gai-li Zhang, Qun-li Wu, Xiu-mei Huang, Ya-zhong Cui, Yu-ling Liu, Zhu-fang Shen, Guo-qing Ma, Hao Lu, Yi Li, Hong Jiang, Xi-yan Yang, Guang-de Zhang, Chen-hua Yang |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Chinese journal of integrative medicine. 28(4) |
| ISSN: |
1672-0415 |
| Popis: |
To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c7.0% and HbA1c6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUCCompared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c7% and6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUCSZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550). |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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