Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.
Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
Tang-min-Ling pills analogue 6g,tid,po
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, China
Jilin Hospital of Integrated Traditional and Western Medicine
Changchun, China
Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
Shanghai, China
The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine
Shenyang, China
Hemoglobin A1c (HbA1c)
The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.
Time frame: 12 weeks after treatment
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)
Time frame: 12 weeks after treatment
symptoms score and Chinese syndrome
Time frame: 12 weeks after treatment
The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests
The number of participants with adverse events were recorded and compared. The blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and observe the safety.
Time frame: 12 weeks after treatment
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The Second Affiliated Hospital to Liaoning University of TCM
Shenyang, China
First Teaching Hospital of Tianjin University of TCM
Tianjin, China