Clinical trial NCT00502008: Effect of Coccinia Cordifolia Extract on Blood Sugar of Newly Diagnosed Diabetics
Official title: Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
India
Coccinia Cordifolia
Coccinia indica
Blood glucose levels
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: Gencor Pacific Group
First posted: 2007-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin
timeFrame: 90 days
Secondary outcomes:
measure: Serum Lipid levels
timeFrame: 90 days
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St John's Research Institute
state: Karnataka
Study officials:
affiliation: St. John's Research Institute
name: Anura V Kurpad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.