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The objective of this study are:
This study is a 2-arm, randomized, double-blind, placebo controlled, cross-over study with a fixed dose regimen. The study will involve twenty (20) healthy subjects. The study will be a comparative study of safety and efficacy of DLBS1033 with placebo. Each study period will consist of 14 days treatment with a 2-week wash-out period in between. The evaluation of safety parameters will be performed at Day 1 (baseline), 7, and 14; while the efficacy parameters will be performed at Day 1, 2, 7, and 14.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Test drug treatment: 3 x 490 mg DLBS1033 daily |
|
| Treatment 2 | Placebo Comparator | Placebo treatment: 3 x 1 tablet daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLBS1033 | Drug | 3 x 490 mg DLBS1033 daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | routine hematology (Hb, Ht, RBC, WBC, Platelet), erythrocyte sedimentation rate (ESR), liver function (ALT, AST, Gamma-GT, alkaline phosphatase), renal function (ureum, creatinine), lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C), fasting blood glucose, routine urine parameters (glucose, bilirubin, ketones, specific gravity, blood, urinary pH, proteins, urobilinogen, nitrites, leucocyte esterase, and urine sediment), stool occult blood, ECG examination, clinical / physical examination | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrinogen level | Day 1, 2, 7, and 14 of treatment | |
| Thrombin time (TT) | Day 1, 2, 7, and 14 of treatment | |
| prothrombin time (PT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danang A Yunaidi, Dr | PT Equilab International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Equilab International | Jakarta | Jakarta Special Capital Region | 12430 | Indonesia |
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| ID | Term |
|---|---|
| C559131 | DLBS 1033 |
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| Drug |
3 x 1 tablet daily |
|
| Day 1, 2, 7, and 14 of treatment |
| activated-partial thromboplastin time (aPTT) | Day 1, 2, 7, and 14 of treatment |
| Number of subjects with adverse events | Day 1 and 7 of treatment |