Back to resultsThe Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)
Primary Purpose
Diabetes Mellitus, Type II
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Extract of Agaricus blazei Murill
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type II focused on measuring Agaricus Blazei Murill, type II DM, insulin index
Eligibility Criteria
Inclusion Criteria: Type II DM Age 20-75 years old Treat with Gliclazide and Metformin Signed informed consent Exclusion Criteria: GOT/GPT >80/80 Creatinine > 2.0 Lactating or pregnant women
Sites / Locations
- Chung-Hua Hsu
Outcomes
Primary Outcome Measures
Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)
Secondary Outcome Measures
Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00131287
Brief Title
The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ECbiotech Taiwan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to examine whether the extract of the Agaricus blazei Murill mushroom is effective in the supplementary treatment of type II DM patients.
Detailed Description
The researchers have the animal model that the extract of the Agaricus blazei Murill mushroom is effective in the treatment of type II DM mice conducted on 2002. The dose effects were also found. The researchers conducted the pilot study also showing the same effects in 2003. So the researchers designed this trial. The elixir of the Agaricus blazei Murill mushroom is popular in Taiwan for chronic diseases, such as type II DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
Keywords
Agaricus Blazei Murill, type II DM, insulin index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
108 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Extract of Agaricus blazei Murill
Primary Outcome Measure Information:
Title
Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)
Secondary Outcome Measure Information:
Title
Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Type II DM
Age 20-75 years old
Treat with Gliclazide and Metformin
Signed informed consent
Exclusion Criteria:
GOT/GPT >80/80
Creatinine > 2.0
Lactating or pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsu Chung-Hua, MD
Organizational Affiliation
Chinese Medicine Dep, Taipei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Hua Hsu
City
Taipei
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)
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