JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

Trials

Liming Chen³  Shuanglei Li⁴  Jianzong Chen²  Dehui Wang⁷  Xuemei Wang⁵  Jing Hu¹  Xiantao Li⁸  Baohe Wang⁸  Hui Wang⁸  Yuzhen Song⁸  Junhua Zhang¹  Hongcai Shang¹  Liping Guo⁶  Ming Ren⁸  Hongbo Cao⁸ 

[1] Evidence Based Medicine Centre of Tianjin, Anshanxidao street, Tianjin, 300193, China;Department of TCM, Xijing hospital, Changlexilu Street, Xi'an, 710032, China;Department of Endocrinology, Metabolic Disease Hospital of Tianjin Medical University, Pingjiang Street, Hexi District, Tianjin, 300211, China;Department of Endocrinology, The First Affiliated Hospital of Guangxi College of TCM, Yuanhu Street, Nanning, 530023, China;Department of Integrated Chinese and Western Medicine, The First Hospital of Peking University, Xishiku Street, Xichen district, Beijing, 100034, China;Baokang hospital, Tianjin university of TCM, Yuquan street, Tanjin, 300193, China;Department of Endocrinology, The Second Affiliated Hospital of Tianjin University of TCM, Zhenli Street, Hebei District, Tianjin, 300150, China;Clinical Assessment Institute, Tianjin University of TCM, Yuquan street, Tianjin, 300193, China

Others  :  1096532
DOI  :  10.1186/1745-6215-11-27

 received in 2009-12-15, accepted in 2010-03-10,  发布年份 2010

【 摘 要 】

Background

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.

Methods/Design

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.

Discussion

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.

Trial registration

Chinese clinical trials register ChiCTR-TRC-00000401

【 授权许可】

   
2010 Cao et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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