Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria: 18 years or older at the time of enrollment in the study. Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011). Fasting blood glucose ≤ 10.0 mmol/L. No previous treatment with metformin or other antidiabetic drugs. Ability and willingness to provide written informed consent and comply with the protocol's requirements. Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study. Exclusion Criteria: The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents. Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health. Pregnancy or lactation. Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis. Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.
Sites / Locations
- Hanoi Hospital of Traditional Medical
- National Hospital of Traditional Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DIDALA
METFORMIN
DIDALA is a herbal medicine, produced from dried mulberry leaves. The drug has been approved by the Drug Administration of Vietnam.