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

Sponsored by:	ECbiotech Taiwan
Information provided by:	ECbiotech Taiwan
ClinicalTrials.gov Identifier:	NCT00131287

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type II	Drug: Extract of Agaricus blazei Murill	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by ECbiotech Taiwan:

Primary Outcome Measures:

Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)

Secondary Outcome Measures:

Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons

Estimated Enrollment:	108
Study Start Date:	July 2005
Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

ecbiotech

Taipei hospital This link exits the ClinicalTrials.gov site

Study ID Numbers:	TH-EC-05-01
Study First Received:	August 16, 2005
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00131287
Health Authority:	Taiwan: Department of Health

Keywords provided by ECbiotech Taiwan:

Agaricus Blazei Murill
type II DM
insulin index

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 16, 2009