|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 16, 2008 | ||||
| Last Updated Date | December 10, 2008 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Glucose Disposal Rate | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00704236 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Fasting Plasma Glucose,Postprandial Plasma Glucose,HbA1c,triglyceride,cholesterol,HDL-c and LDL-c,lipid levels ,body weight, blood pressure | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes | ||||
| Official Title ICMJE | Phase 4 Study on the Effect of Insulin Resistance With Traditional Chinese Treatment in Type 2 Diabetes | ||||
| 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 | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Type 2 Diabetes | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | February 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00704236 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CCEMD003 | ||||
| Study Sponsor ICMJE | Shanghai Jiao Tong University of Medicine | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Shanghai Jiao Tong University School of Medicine | ||||
| Verification Date | December 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||