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

Phase 4

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment); Drug: Placebo

• Registration Number: NCT00704236
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study Completion: 2008-02
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-10
• Last Update Posted: 2008-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment)	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Glucose Disposal Rate

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China