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NCT00155675 Clinical Trial

Pseudodrynaria Coronana (Wall) Ching

Osteoporosis Clinical Trial

Official title:
Clinical Effect of Traditional Chinese Medicine - "Gusuibu"

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00155675
Other study ID # 900505
Secondary ID CCMP90-RD-114
Status Completed
Phase Phase 1
First received September 9, 2005
Last updated January 11, 2010
Start date January 2000
Est. completion date January 2001

Study information
Verified date December 2009
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date January 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 70 Years
Eligibility Inclusion Criteria:

- postmenopausal osteoporosis

Exclusion Criteria:

- Insulin dependent diabetes

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• GUSUIBU

Locations
Country Name City State
Taiwan National Taiwan University Medical Center Taipei 7, Chung-Shan S. Road

Sponsors (2)
Lead Sponsor Collaborator
National Taiwan University Hospital Sheng Chang Pharmaceutical

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary one year
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