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临床试验/NCT00502008
NCT00502008已完成不适用

Efficacy of Coccinia Cordifolia Extract in Improving Blood Glucose Levels of Newly Diagnosed Diabetic Patients

St. John's Research Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin

研究概览

简要总结

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.

详细描述

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%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Presence of any chronic disease or organ failure
  • Concurrent use of medication to control blood glucose levels

结局指标

主要结局

Fasting and Post Prandial Blood Glucose, Glycosylated Hemoglobin

时间窗: 90 days

次要结局

  • Serum Lipid levels(90 days)

研究者

申办方类型
Other

研究点 (2)

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