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

January 4, 2010 updated by: ECbiotech Taiwan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

108

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 886
        • Chung-Hua Hsu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECbiotech Taiwan

Investigators

  • Principal Investigator: Hsu Chung-Hua, MD, Chinese Medicine Dep, Taipei Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 16, 2005

First Posted (Estimate)

August 18, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-EC-05-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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