JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial.
JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial.
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DOI：
10.1186/1745-6215-11-27
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发表时间：
2010-03-10
期刊：
影响因子：
2.5
通讯作者：
Chen L
中科院分区：
文献类型：
--
作者：
Cao H;Ren M;Guo L;Shang H;Zhang J;Song Y;Wang H;Wang B;Li X;Hu J;Wang X;Wang D;Chen J;Li S;Chen L
糖尿病前期是一个日益增长的健康问题，其中大部分患者发展为完全的2型糖尿病。对糖尿病前期进行有效的干预可以预防或延缓糖尿病的发生或发展。金芪降糖片的药效学及临床前研究表明，其对糖尿病前期有一定的治疗作用。本研究采用随机对照试验（RCT）。研究期限为24个月（12个月用于干预，12个月用于随访）。参与者来自中国四个城市：北京，天津，西安和南宁。将400名参与者随机分配至治疗组（JQJT片剂）和对照组（安慰剂）;各200名参与者。纳入本研究的患者必须通过西医标准和中医标准诊断为糖尿病前期。终点指标包括：糖尿病发病率和逆转率。主要观察指标包括：口服葡萄糖耐量试验、胰岛素释放试验、糖化血红蛋白（HA 1c）。次要结局指标包括：SF-36量表评分、中医症状评分、血脂检测。安全指标包括：一般医疗检查;定期验血、验尿;心电图（ECG）、肝功能（ALT）和肾功能（BUN、Creditin）检测;不良事件记录，如头痛、晕厥等。将实施定性控制，并在整个研究过程中形成多个标准操作流程（SOP）：实验室质量控制措施;研究者和参与者的依从性控制;研究前的研究者培训;监督;研究药物管理和其他。本研究旨在评价金芪降糖片治疗糖尿病前期的有效性和安全性。中国临床试验注册ChiCTR-TRC-00000401
Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Chinese clinical trials register ChiCTR-TRC-00000401
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影响因子：
158.5
作者：
Knowler, WC;Barrett-Connor, E;Nathan, DM
通讯作者：
Nathan, DM
DOI：
10.1016/s0197-2456(97)00151-7
发表时间：
1998-04-01
期刊：
CONTROLLED CLINICAL TRIALS
影响因子：
--
作者：
Azen, SP;Peters, RK;Buchanan, TA
通讯作者：
Buchanan, TA
影响因子：
120.7
作者：
Chiasson, JL;Josse, RG;Laakso, M
通讯作者：
Laakso, M
影响因子：
168.9
作者：
Gerstein, H. C.;Yusuf, S.;Ryden, L.
通讯作者：
Ryden, L.
影响因子：
3.5
作者：
Pan, CY;Lu, JM;Cui, L
通讯作者：
Cui, L