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CompletedNCT00499148Updated Jul 30, 2010

Efficacy Study Testing Herbal Extract on Metabolic Parameters in Subjects With Type 2 Diabetes

A Phase 2/3 interventional study of herbal extract; root of woody shrub grown in India/Sri-Lanka in Type 2 Diabetes, sponsored by Abbott Nutrition. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-07-30.

Sponsored by Abbott Nutrition · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of the study was to evaluate the effect of an herbal extract on postprandial glycemia following a meal.

02

Conditions studied

03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 59 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Abbott Nutrition is the lead sponsor of 153 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • type 2 diabetes
  • 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

Exclusion Criteria:

  • Uses insulin for glucose control or has type 1 diabetes
  • 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
59 participants (actual)

Interventions

  • Otherherbal extract; root of woody shrub grown in India/Sri-Lanka
06

What researchers measure

Primary outcomes

  1. positive AUC for plasma glucose

    Time frame: 4 hours

Secondary outcomes

  1. positive AUC for serum insulin; adjusted peak values for plasma glucose and serum insulin; baseline plasma glucose and serum insulin concentrations; adjusted values for plasma glucose and serum insulin at individual postprandial time points.

    Time frame: 4 hours

07

Study locations

2 sites
  • Radiant Research
    Edina, Minnesota 55435, United States
  • Radiant Research
    Cincinnati, Ohio 45249, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00499148
Lead sponsor
Abbott Nutrition
First posted
Jul 11, 2007
Start date
Aug 2006
Primary completion
Aug 2007
Completion
Oct 2007
Last update
Jul 30, 2010

Study contacts

Jennifer A. Williams, MPH
study director · Abbott Nutrition

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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