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Effect of Coccinia Cordifolia Extract on Blood Sugar of Newly Diagnosed Diabetics

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ClinicalTrials.gov Identifier: NCT00502008
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : July 17, 2007
Gencor Pacific Group
Information provided by:
St. John's Research Institute

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.

Condition or disease Intervention/treatment
Diabetes Drug: Coccinia Cordifolia (herbal extract)

Detailed Description:

The prevalence of diabetes is increasing in all countries, especially India at an alarming rate. Appropriate interventions in the form of weight reduction, changes in dietary habits and increased physical activity could help in preventing or delaying the onset of diabetes and reducing the burden due to non communicable diseases in India.

Plants or their extracts may also have a potential therapeutic role in the treatment for diabetes. Coccinia indica (synonym Coccinia cordifolia), a herb that belongs to the Cucurbitaceae family and that grows abundantly in India, is widely used in the traditional treatment of diabetes mellitus. Coccinia leaves, when administered orally twice a day for six weeks, to patients with untreated but uncomplicated maturity onset diabetes demonstrated hypoglycemic activity with significant improvement in glucose tolerance. The aim of the present study was to evaluate the effectiveness of Coccinia Cordifolia on the blood glucose levels of newly detected type 2 diabetic patients requiring only behavioral or lifestyle intervention.

The study was a double blind, placebo controlled, randomized trial. The study was carried out at Nutrition and Lifestyle Management Clinic, St. John's Medical College Hospital. After recruitment , the diabetic subjects were assigned either to the experimental or placebo group. They were provided with the extract for a period of 90 days. Prior to the intervention, the subjects underwent baseline investigations which included anthropometric, biochemical, dietary and physical activity assessment. These investigations were repeated at day 45 and day 90 of the study. The compliance of the subjects to the ingestion of capsules was documented every week when they reported to the Nutrition Clinic. All the study subjects were provided with standard dietary and physical activity advice for the control of their blood sugars. The compliance of the subjects to the prescribed diet and physical activity was assessed weekly by asking the subjects to rate their compliance on a scale of 0-100%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients
Study Start Date : November 2005
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Primary Outcome Measures :
  1. Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Serum Lipid levels [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502008

St John's Research Institute
Bangalore, Karnataka, India, 560034
Sponsors and Collaborators
St. John's Research Institute
Gencor Pacific Group
Principal Investigator: Anura V Kurpad, MD, PhD St. John's Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00502008     History of Changes
Other Study ID Numbers: NS-2-2007
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: July 17, 2007
Last Verified: July 2007

Keywords provided by St. John's Research Institute:
Coccinia Cordifolia
Coccinia indica
Blood glucose levels