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

December 10, 2008 updated by: Shanghai Jiao Tong University School of Medicine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment)
50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica
Placebo Comparator: B
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Glucose Disposal Rate

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 16, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2008

Last Update Submitted That Met QC Criteria

December 10, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEMD003

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.

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