- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502008
Effect of Coccinia Cordifolia Extract on Blood Sugar of Newly Diagnosed Diabetics
Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560034
- St John's Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with clinical Diagnosis of Type 2 diabetes requiring only behavioral or lifestyle intervention.
- Fasting blood glucose in the range of 110-180 mg/dl
- Age range - 35 to 60 years
- Willing to participate in the study and perform all measurements
Exclusion Criteria:
- Presence of any chronic disease or organ failure
- Concurrent use of medication to control blood glucose levels
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum Lipid levels
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anura V Kurpad, MD, PhD, St. John's Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NS-2-2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on Coccinia Cordifolia (herbal extract)
-
Gadjah Mada UniversityEnrolling by invitationAllergic Rhinitis | Allergic Rhinitis Due to House Dust MiteIndonesia
-
Rosenberg European Academy of AyurvedaEUROPEAN PROFESSIONAL ASSOCIATION OF AYURVEDA PRACTITIONERS AND THERAPISTSCompletedDiabetic Neuropathies | Diabetic Neuropathy | Diabetic Polyneuropathy | Diabetic NeuralgiaIndia
-
University of California, DavisCompletedErythema | Wrinkles | Transepidermal Water Loss | Sebum Production | Stool Microbiome | Facial Brrightness | Facial ShineUnited States
-
Korea Health Industry Development InstituteUnknown
-
Bionorica SECompleted
-
University of ReginaNational Football League (NFL); My Next Health Inc.Not yet recruiting
-
Zhejiang UniversityRecruitingChild, Only | Body HeightChina
-
Olive Lifesciences Pvt LtdCompletedHyperlipidemia | PrediabetesIndia
-
Aventure ABActive, not recruiting
-
Arjuna Natural LimitedKU Leuven; ZB Sports Development BVBAUnknown