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Clinical study on Lianmei Rougui Recipe treatment for type 2 diabetes mellitus patients with the syndrome of heat in intestinal and cold in Ga

Early Phase 1
Conditions
type 2 diabetes mellitus
Registration Number
ITMCTR2023000031
Lead Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Patients with type 2 diabetes mellitus who were newly diagnosed within half a year and did not receive any hypoglycemic drug treatment ;
the diagnostic criteria of Traditional Chinese Medicine syndromes of intestinal heat and liver cold syndrome ;
aged between 18-65 years old ;
fasting plasma glucose concentration < 11.1mmol / L, and glycated hemoglobin A1c< 9.5 % ;
patients were informed and voluntarily signed informed consent.

Exclusion Criteria

In the past 1 month,patients had the acute metabolic disorders such as diabetic ketoacidosis or severe infection ;
patients with severe primary diseases such as liver, kidney, hematopoietic system, malignant tumor or severe mental illness ;
those who did not cooperate during the introduction period ( referring to those who could not cooperate with diet and exercise control and lifestyle adjustment ) ;
pregnant or lactating women ;
patients participated in other clinical trials in the past 3 months ;
Patients with contraindications to metformin or unsuitable for metformin.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
plasma glucose concentration 2 hours after meals;fasting plasma glucose concentration;glycated hemoglobin A1c;
Secondary Outcome Measures
NameTimeMethod
low-density lipoprotein cholesterol;insulin resistance index;fasting fingertip blood glucose;fingerstick blood glucose 2 hours after meals;high-density lipoprotein cholesterol;total cholesterol;triglycerides;plasma insulin;
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