NCT00131287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 5, 2010

Status Verified

April 1, 2007

First QC Date

August 16, 2005

Last Update Submit

January 4, 2010

Conditions

Diabetes Mellitus, Type II

Keywords

Agaricus Blazei Murilltype II DMinsulin index

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Glucose, cholesterol, triglyceride, leptin, adiponectin comparisons

Interventions

Extract of Agaricus blazei MurillDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II DM
  • Age 20-75 years old
  • Treat with Gliclazide and Metformin
  • Signed informed consent

You may not qualify if:

  • GOT/GPT \>80/80
  • Creatinine \> 2.0
  • Lactating or pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung-Hua Hsu

Taipei, 886, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hsu Chung-Hua, MD

    Chinese Medicine Dep, Taipei Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

July 1, 2005

Study Completion

December 1, 2006

Last Updated

January 5, 2010

Record last verified: 2007-04

Locations

TW(1)