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Study for the effect of pre-diabetes IGT Chinese medicine intervention based on APP management and 'treatment before disease onset' theory

Phase 1
Conditions
Type 2 of diabetes
Registration Number
ITMCTR1900002375
Lead Sponsor
Guang'anmen Hospital, 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

(1) Those who meet the diagnostic criteria for pre-diabetes IGT in Western medicine;
(2) The newly diagnosed pre-diabetes, after one month of regular diet control and exercise therapy, still meet the diagnostic criteria for pre-diabetes;
(3) obese or overweight body type, body mass index (BMI) = 24kg / m2;
(4) Aged 18 to 70 years old male and female;
(5) According to the 2017 Guidelines for Evidence-based Clinical Practice of Traditional Chinese Medicine for Diabetes and Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine, the diagnosis of dampness and spleen syndrome, spleen deficiency and dampness syndrome, liver qi stagnation syndrome and qi and yin deficiency syndrome standard;
(6) Sign the informed consent form.

Exclusion Criteria

(1) Acute cardiovascular or cerebrovascular events or myocardial infarction within 6 months;
(2) severe liver and kidney dysfunction;
(3) stress or secondary hyperglycemia;
(4) Those who are unwilling to cooperate (can not cooperate with diet control, or do not use drugs according to regulations to affect the efficacy);
(5) mental illness;
(6) Women who are pregnant or breastfeeding, and women who plan to have a pregnancy or have no contraceptive plan;
(7) Those who may be allergic to the test drug;
(8) Those who combine other endocrine diseases or other serious primary diseases;
(9) Those who take other hypoglycemic agents at the same time.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BMI;Glycated hemoglobin;blood sugar;TCM symptom score;
Secondary Outcome Measures
NameTimeMethod
ECG;liver function;Kidney function;Urine routine;Stool routine;Blood lipid;
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