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

This study has been completed.
Sponsor:
Information provided by:
ECbiotech Taiwan
ClinicalTrials.gov Identifier:
NCT00131287
First received: August 16, 2005
Last updated: January 4, 2010
Last verified: April 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00131287     History of Changes
Other Study ID Numbers: TH-EC-05-01
Study First Received: August 16, 2005
Last Updated: January 4, 2010
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014