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Sponsored by: |
Shanghai Jiao Tong University of Medicine |
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Information provided by: | Shanghai Jiao Tong University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00704236 |
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
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Coptis Chinensis, Astragalus mambranesceus, Lonicera Japonica (Traditional Chinese Treatment) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes |
Enrollment: | 43 |
Study Start Date: | September 2006 |
Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
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A: Experimental |
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
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B: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Shanghai Jiao Tong University School of Medicine | |
Shanghai, China, 200025 |
Principal Investigator: | Guang Ning, MD. PHD | Shanghai Jiao Tong University School of Medicine |
Study ID Numbers: | CCEMD003 |
Study First Received: | June 16, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00704236 History of Changes |
Health Authority: | China: Ethics Committee |
Traditional Chinese Treatment |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Insulin Resistance Glucose Metabolism Disorders |