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

NCT ID: NCT00131287

Last Updated: 2010-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Diabetes Mellitus, Type II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Extract of Agaricus blazei Murill

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ECbiotech Taiwan

OTHER

Sponsor Role: lead

Principal Investigators

Hsu Chung-Hua, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Medicine Dep, Taipei Hospital

Locations

Chung-Hua Hsu

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TH-EC-05-01

Identifier Type: -

Identifier Source: org_study_id