This study is a randomized, positive drug parallel-controlled clinical trial in participants with glucose and lipid metabolism disturbances. A total of 96 participants will be recruited for the study, all of whom are diagnosed as type 2 diabetes mellitus combined with dyslipidemia. The subjects will be divided randomly into two groups and treated with either Jiangtang Tiaozhi Recipe or metformin. After 12 weeks of treatment, therapeutic effect of Jiangtang Tiaozhi Recipe will be evaluated based on the changes of HbA1c, fasting blood glucose, postprandial blood glucose, blood lipid, waist circumference, body mass index.
The diagnosis criteria of type 2 diabetes mellitus are in accordance to 1999 World Health Organization (WHO) diabetes diagnostic criteria. The diagnosis criteria of dyslipidemia are based on the Guidelines for the Prevention and Treatment of Dyslipidemia in Chinese adults (2016, revision edition). The outcomes mainly include HbA1c, fasting blood glucose, postprandial blood glucose, body weight, waist circumference, blood lipid and TCM symptom score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
The metformin tablets (500mg) will be administrated.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChange from Baseline HbA1c at 12 weeks
Time frame: 0 week, 12 weeks
Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Postprandial Blood Glucose at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline Low Density Lipoprotein at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline Triglyceride at 12 weeks
Time frame: 0 week, 12 weeks
Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks
Time frame: 0 week, 4 weeks, 8 weeks,12 weeks
Change from Baseline Total Cholesterol at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline High Density Lipoprotein at 12 weeks
Time frame: 0 week, 12 weeks
Change from Baseline TCM Symptom Score at 12 weeks
Time frame: 0 week, 12 weeks
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