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

This study has been completed.
Sponsor:
Collaborator:
Gencor Pacific Group
Information provided by:
St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT00502008
First received: July 16, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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 Intervention
Diabetes
Drug: Coccinia Cordifolia (herbal extract)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients

Resource links provided by NLM:


Further study details as provided by St. John's Research Institute:

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

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

Enrollment: 60
Study Start Date: November 2005
Study Completion Date: May 2007
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%.

  Eligibility

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502008

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

No publications provided by St. John's Research Institute

Additional 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
Study First Received: July 16, 2007
Last Updated: July 16, 2007
Health Authority: India: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014