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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00154609
Other study ID # 930701
Secondary ID
Status Recruiting
Phase Phase 1
First received September 9, 2005
Last updated January 20, 2006
Start date January 2002

Study information

Verified date January 2002
Source National Taiwan University Hospital
Contact Liu Hwa-Chang, Ph.D
Phone 886-2-23956988
Email hcliu@ha.mc.ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial Summary

We, the investigators at National Taiwan University Hospital, have determined the therapeutic and toxic effects of the traditional herb on the ovariectomized Wistar rat.

The final years will determine its effects on the therapy of women who are over 45 years old and postmenopausal with osteoporosis.


Description:

Research of this traditional chinese clinical medicine, Gusuibu, curative effect is planned for three years time. The entire study aims to evaluate the effect of the traditional chinese medicine on postmenopausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal women with established osteoporosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
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: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Gu-Sui-Bu (Davallia Divaricata)


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The project is aimed to investigate the clinical effects of the water extract of Gu-Sui-Bu from the aspects of animal and clinic studies.
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