Type 2 Diabetic Patients Maturameha, type 2 diabetes, Placebo
Conditions
Interventions
Participants will receive Maturameha extract at a dose of 350 milligrams, taken as one capsule once a day, 30 minutes before lunch, as add-on therapy to their existing dose of metformin (500-2,000 mil
Experimental Drug,Placebo Comparator No treatment
Maturameha Extract,Placebo
Sponsors
Medicinal Innovation Center of MFU (MPIC)
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 35 - 65 years. 2. Diagnosed with type 2 diabetes according to the World Health Organization (WHO) diagnostic criteria for type 2 diabetes. 3. Have been on a stable dose of metformin (500-2,000 milligrams per day) for at least 3 months prior. 4. Have fasting plasma glucose levels between 126 - 250 milligrams per deciliter after fasting for at least 8 hours, or 2-hour postprandial plasma glucose levels of 200 milligrams per deciliter or higher. 5. Have a body mass index (BMI) greater than 18 but not exceeding 40 kilograms per square meter. 6. Understand the information and consent to participate in the research by signing a written consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with type 1 diabetes, gestational diabetes, or other types of diabetes. 2. Have used weight control drugs or any oral antidiabetic drugs or insulin other than metformin in the past three months. 3. Have or have had the following conditions: heart failure, stroke, diabetic ketoacidosis, unconsciousness due to diabetes, partial resection of the small intestine, anemia, heart disease, lung disease, polycystic ovary syndrome, thyroid disease, or are prone to dehydration. 4. Have cirrhosis, chronic hepatitis, liver cancer, severe liver abnormalities, or serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, or alkaline phosphatase more than 2.5 times the upper normal range. 5. Have kidney abnormalities or blood creatinine levels greater than 1.5 milligrams per deciliter. 6. Have a glomerular filtration rate (GFR) less than 60 milliliters per minute. 7. Have uncontrolled high blood pressure or blood pressure levels greater than 160/100 millimeters of mercury. 8. Have high blood lipids or triglyceride levels greater than 500 milligrams per deciliter. 9. Have severe complications from diabetes, such as blindness, kidney failure, heart disease, paralysis, numbness, or gangrene, especially in the feet. 10. Are undergoing treatment with estrogen, steroids, beta-blockers, or thiazides. 11. Have a history of severe anaphylaxis, hypersensitivity reactions, or any significant clinical reaction to metformin, the herbal components of the traditional herbal medicine formula, other herbal medicines, or other herbs. 12. Have participated in other clinical trials within one month prior to the start of the study. 13. Are pregnant, breastfeeding, or planning to become pregnant. 14. Have mental illness or chronic alcoholism. 15. Have a history of drug or herbal allergies. 16. Are unable to comply with the research rules or follow-up schedule as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FBG at 12 weeks Lab investigation,HbA1C at 12 weeks Lab investigation | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometric parameters at 12 weeks Personal scale and soft metric tape,Lipid profile at 12 weeks Lab investigation,Liver and renal function test at 12 weeks Lab investigation,Adverse events at week 4, week 8 and week 12 Questionnaire | — |
Countries
Thailand
Contacts
Public ContactNanthakarn Woottisin
School of Integrative Medicine, Mae Fah Luang University
Outcome results
None listed