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Completed

NCT Number: NCT00704236

Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT) on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind, randomized, parallel control and prospective study This traditional compound Chinese herb preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected by The Chinese Academy of Medical Sciences among those traditionally considered effective and safe in the treatment of diabetes.

Patients enrolled were randomized into TCT group and placebo group administrated with TCT and placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end point

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed type 2 diabetes poorly controlled by diet only for one month
  • Obese with a BMI of 23-35 kg/m2

Exclusion criteria

  • Those patients used any drugs for treatment of diabetes
  • Patients with evidence of cardiac, hepatic, renal, other chronic diseases or acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma
  • Women who were pregnant or planned pregnant.

Treatment and study plan

Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment)

Drug

50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica

Placebo

Drug

Primary outcomes

  1. Glucose Disposal Rate

Secondary outcomes

  1. Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes

Important dates

Study start
2006
Study completion
2008
First posted
Jun 24, 2008
Registry last updated
Dec 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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