None listed
Conditions
Interventions
Drug : Galgeun-tang extract granules or placebo administration for 12 weeks.
3 pakets (4g/packet)/day before or between meals.
Sponsors
Dongguk University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 19-74 years (2) Had fasting plasma glucose concentration of 100 mg/dL or higher, or glycated hemoglobin of 5.7% or more and less than 8.5% despite dietary control and exercise therapy (3) Subject who has received sufficient explanation prior to participation in the study and and voluntarily signed a written consent approved by the IRB
Exclusion criteria
Exclusion criteria: (1) Had type 1 diabetes (2) Reported a diagnosis of type 2 diabetes for more than 2 years (3) Taken drugs for glycemic control within 2 months (4) Those who received systemic corticosteroids within 4 weeks prior to the screening visit (5) Those who require treatment for acute/chronic inflammation or malignant tumors (6) Impaired liver function (ALT or AST is more than 3 times the upper limit of normal in the institution at the time of screening) (7) Patients with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke (8) Severe kidney disease such as acute or chronic renal failure or nephrotic syndrome (Creatinine > 2.0 mg/dL at the time of screening) (9) Subjects with a history of clinically significant hypersensitivity reactions (10) Women who are pregnant, lactating, or planning to become pregnant (11) Subjects with a history of alcohol abuse or drug abuse within the past year (12) Subjects with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucosegalactose malabsorption (13) Subjects who have taken other clinical trial drugswithin 3 months (14) Subjects who has a medical condition that can affect the results of the study or those who are thought to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose;Oral glucose tolerance test;Blood Glucose Area Under the Curve (0~2hr);Insulin;HOMA-IR;Serum lipid concentration (TG, TC, HDL-C);Body measurement (weight, body mass index, body composition, waist circumference);Fecal microbiome;Serum metabolite profile;Safety outcome (AST, ALT, BUN, Creatinine) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyungsun Han
Korea Institute of Oriental Medicine
Outcome results
None listed