| Trial ID: | L3526 |
| Source ID: | NCT01005069
|
| Associated Drug: |
Dlbs-32
|
| Title: |
Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: DLBS-32|DRUG: DLBS-32|DRUG: DLBS-32|DRUG: DLBS-32|DRUG: Placebo capsule
|
| Outcome Measures: |
Primary: Reduction of venous Fasting Plasma Glucose from baseline, every 2-week interval over 6 weeks of treatment | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: Dexa Medica Group
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-10
|
| Completion Date: |
2010-08
|
| Results First Posted: |
|
| Last Update Posted: |
2010-09-28
|
| Locations: |
Sanglah Hospital Denpasar, Denpasar, Bali, Indonesia|RSUD Tarakan, Jakarta Pusat, DKI Jakarta, Indonesia
|
| URL: |
https://clinicaltrials.gov/show/NCT01005069
|
