NCT00502008

Brief Summary

The purpose of the study was to evaluate the effectiveness of Coccinia Cordifolia (synonym Coccinia indica) on the blood glucose levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle intervention. The hypothesis of the study is that there will be significant decrease in the blood glucose levels after a period of 90 days in the diabetic patients who consumed the coccinia extract.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
Last Updated

July 17, 2007

Status Verified

July 1, 2007

First QC Date

July 16, 2007

Last Update Submit

July 16, 2007

Conditions

Diabetes

Keywords

DiabetesIndiaCoccinia CordifoliaCoccinia indicaBlood glucose levels

Outcome Measures

Primary Outcomes (1)

  • Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin

    90 days

Secondary Outcomes (1)

  • Serum Lipid levels

    90 days

Interventions

Coccinia Cordifolia (herbal extract)DRUG

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with clinical Diagnosis of Type 2 diabetes requiring only behavioral or lifestyle intervention.
  • Fasting blood glucose in the range of 110-180 mg/dl
  • Age range - 35 to 60 years
  • Willing to participate in the study and perform all measurements

You may not qualify if:

  • Presence of any chronic disease or organ failure
  • Concurrent use of medication to control blood glucose levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John's Research Institute

Bangalore, Karnataka, 560034, India

Location

Related Publications (1)

  • Kuriyan R, Rajendran R, Bantwal G, Kurpad AV. Effect of supplementation of Coccinia cordifolia extract on newly detected diabetic patients. Diabetes Care. 2008 Feb;31(2):216-20. doi: 10.2337/dc07-1591. Epub 2007 Nov 13.

    PMID: 18000183DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Anura V Kurpad, MD, PhD

    St. John's Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

November 1, 2005

Study Completion

May 1, 2007

Last Updated

July 17, 2007

Record last verified: 2007-07

Locations

IN(1)