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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

Traditional Chinese medicine for prevention, treatment and management of Diabetes mellitus based on precision medicine model

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR1900002375
Enrollment
Unknown
Registered
2019-06-01
Start date
2019-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 of diabetes

Interventions

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
BMI;Glycated hemoglobin;blood sugar;TCM symptom score;

Secondary

MeasureTime frame
ECG;liver function;Kidney function;Urine routine;Stool routine;Blood lipid;

Countries

China

Contacts

Public ContactQing Ni

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

13701253942@163.com+86 13701253942

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026