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The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)

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ClinicalTrials.gov Identifier: NCT00131287
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
ECbiotech Taiwan

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: Extract of Agaricus blazei Murill Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)

Secondary Outcome Measures :
  1. Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131287


Locations
Taiwan
Chung-Hua Hsu
Taipei, Taiwan, 886
Sponsors and Collaborators
ECbiotech Taiwan
Investigators
Principal Investigator: Hsu Chung-Hua, MD Chinese Medicine Dep, Taipei Hospital

ClinicalTrials.gov Identifier: NCT00131287     History of Changes
Other Study ID Numbers: TH-EC-05-01
First Posted: August 18, 2005    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: April 2007

Keywords provided by ECbiotech Taiwan:
Agaricus Blazei Murill
type II DM
insulin index

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases