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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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%.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Interventions

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Coccinia Cordifolia (herbal extract)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anura V Kurpad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. John's Research Institute

Locations

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St John's Research Institute

Bangalore, Karnataka, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED

PMID: 18000183 (View on PubMed)

Other Identifiers

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NS-2-2007

Identifier Type: -

Identifier Source: org_study_id