Back to resultsPseudodrynaria Coronana (Wall) Ching
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
GUSUIBU
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria: postmenopausal osteoporosis Exclusion Criteria: Insulin dependent diabetes
Sites / Locations
- National Taiwan University Medical Center
Outcomes
Primary Outcome Measures
one year
Secondary Outcome Measures
Full Information
NCT ID
NCT00155675
First Posted
September 9, 2005
Last Updated
January 11, 2010
Sponsor
National Taiwan University Hospital
Collaborators
Sheng Chang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00155675
Brief Title
Pseudodrynaria Coronana (Wall) Ching
Official Title
Clinical Effect of Traditional Chinese Medicine - "Gusuibu"
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Sheng Chang Pharmaceutical
4. Oversight
5. Study Description
Brief Summary
The Study to evaluate the clinical effect of "Gusuibu" lasts for 3 years. It aims to evaluate its effect on bone density of postmenopausal osteoporosis. Besides, its effects on the liver, kidney and the hematological influence will be evaluated, too.
Detailed Description
Research of the this traditional chinese medicine clinucal, Gusuibu, curative effect is plan three years time. The entire studyaims to evaluated the effect of the traditional chinese medicine on postmenpausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal woman with established osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GUSUIBU
Primary Outcome Measure Information:
Title
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
postmenopausal osteoporosis
Exclusion Criteria:
Insulin dependent diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Hwa-Chang, M.D
Organizational Affiliation
National Taiwan University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Medical Center
City
Taipei
State/Province
7, Chung-Shan S. Road
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Pseudodrynaria Coronana (Wall) Ching
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