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

Diabetes Mellitus, Type II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131287
• Other study ID #: TH-EC-05-01
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: January 4, 2010
• Start date: July 2005
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: ECbiotech Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

Drug:
• Extract of Agaricus blazei Murill

Locations

Country	Name	City	State
Taiwan	Chung-Hua Hsu	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
ECbiotech Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction of glycated hemoglobin (HAb1C) and insulin resistance(HOMA-IR)
Secondary	Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons