Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502008
Status:
COMPLETED
Last Update Posted:
2007-07-17
First Post:
2007-07-16
Brief Title:
Effect of Coccinia Cordifolia Extract on Blood Sugar of Newly Diagnosed Diabetics
Sponsor:
St Johns Research Institute
Organization:
St Johns Research Institute
Study Overview
Official Title:
Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Johns 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
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 Johns 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None