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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment I | Experimental |
| |
| Treatment II | Experimental |
| |
| Treatment III | Experimental |
| |
| Treatment IV | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS-32 | Drug | DLBS-32 50 mg once daily and lifestyle modification |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of venous Fasting Plasma Glucose from baseline | every 2-week interval over 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of 2h-post-prandial plasma glucose from baseline | six weeks | |
| Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline | six weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ketut Suastika, Prof. Dr. | Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital | Principal Investigator |
| Nuniek E Nugrahini, Dr. | Department of internal medicine, RSUD Tarakan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanglah Hospital Denpasar | Denpasar | Bali | Indonesia | |||
| RSUD Tarakan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| DLBS-32 |
| Drug |
DLBS-32 100 mg once daily and lifestyle modification |
|
| DLBS-32 | Drug | DLBS-32 200 mg once daily and lifestyle modification |
|
| DLBS-32 | Drug | DLBS-32 300 mg once daily and lifestyle modification |
|
| Placebo capsule | Drug | Placebo capsules once daily and lifestyle modification |
|
| Change of high sensitivity C-reactive protein (hs-CRP) from baseline |
| six weeks |
| Liver Function, Renal Function, Adverse events | six weeks |
| Change in HbA1c from baseline | six weeks |
| Change in lipid profile from baseline | six weeks |
| Jakarta Pusat |
| DKI Jakarta |
| Indonesia |
| D006946 | Hyperinsulinism |