Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01005069 |
Recruitment Status
:
Completed
First Posted
: October 30, 2009
Last Update Posted
: September 28, 2010
|
Sponsor:
Dexa Medica Group
Information provided by:
Dexa Medica Group
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | October 28, 2009 | ||||||
First Posted Date ICMJE | October 30, 2009 | ||||||
Last Update Posted Date | September 28, 2010 | ||||||
Study Start Date ICMJE | October 2009 | ||||||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Reduction of venous Fasting Plasma Glucose from baseline [ Time Frame: every 2-week interval over 6 weeks of treatment ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01005069 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus | ||||||
Official Title ICMJE | Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||
Condition ICMJE | Diabetes Mellitus, Type 2 | ||||||
Intervention ICMJE |
|
||||||
Study Arms |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
72 | ||||||
Original Estimated Enrollment ICMJE |
100 | ||||||
Actual Study Completion Date | August 2010 | ||||||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
Ages | 18 Years to 60 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Indonesia | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01005069 | ||||||
Other Study ID Numbers ICMJE | DLBS-32-0309 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | Dexa Medica Group | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Dexa Medica Group | ||||||
Verification Date | September 2010 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |