Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes
NCT ID: NCT00499148
Last Updated: 2010-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
59 participants
INTERVENTIONAL
2006-08-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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herbal extract; root of woody shrub grown in India/Sri-Lanka
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 75 years of age
* Male or non-pregnant, non-lactating female, at least 6 weeks postpartum
* If of childbearing potential, is practicing birth control
* BMI is more than or equal to 18kg/m2 and less than or equal to 35kg/m2
* If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit
Exclusion Criteria
* History of diabetic ketoacidosis.
* Current infection; surgery or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks.
* Active malignancy
* Significant cardiovascular event less than or equal to 6 months prior to screening visit or history of congestive heart failure
* End state organ failure or status post organ transplant
* History of renal disease
* Current hepatic disease
* History of severe gastroparesis
* Has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV
* Currently taking herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, during the past 4 weeks that could profoundly affect blood glucose
* Clotting or bleeding disorders
* Allergic or intolerant to any ingredient found in the study products
18 Years
75 Years
ALL
No
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Abbott Nutrition
Principal Investigators
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Jennifer A. Williams, MPH
Role: STUDY_DIRECTOR
Abbott Nutrition
Locations
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Radiant Research
Edina, Minnesota, United States
Radiant Research
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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BJ82
Identifier Type: -
Identifier Source: org_study_id