The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Sanglah Hospital Denpasar
Denpasar, Bali, Indonesia
RSUD Tarakan
Jakarta Pusat, DKI Jakarta, Indonesia
Reduction of venous Fasting Plasma Glucose from baseline
Time frame: every 2-week interval over 6 weeks of treatment
Reduction of 2h-post-prandial plasma glucose from baseline
Time frame: six weeks
Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline
Time frame: six weeks
Change of high sensitivity C-reactive protein (hs-CRP) from baseline
Time frame: six weeks
Liver Function, Renal Function, Adverse events
Time frame: six weeks
Change in HbA1c from baseline
Time frame: six weeks
Change in lipid profile from baseline
Time frame: six weeks
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DLBS-32 300 mg once daily and lifestyle modification
Placebo capsules once daily and lifestyle modification