OsteoporosisPhase 1NCT00154609
Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis
A Phase 1 study testing Gu-Sui-Bu (Davallia Divaricata) in people with Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Gu-Sui-Bu (Davallia Divaricata)
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2002to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal osteoporosis
Who cannot join
- Insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Medical Center
Taipei, 7, Chung-Shan South Road, 100
Liu Hwa-Chang, Ph.D, 886-2-23956988, hcliu@ha.mc.ntu.edu.tw
About this study
Official title: The Use Tradition Chinese Native Medicine Treats the Osteoporosis Research
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.
Read the detailed 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.
- Conditions
- Osteoporosis
- Being tested
- Gu-Sui-Bu (Davallia Divaricata)
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gu-Sui-Bu (Davallia Divaricata)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liu Hwa-Chang, Ph.D, Study chair, National Taiwan University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154609
- Sponsor's protocol ID
- 930701
- Status last verified
- Jan 2002
- First submitted
- 9 Sep 2005
- Last updated
- 23 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Tradition Chinese Native Medicine Treats the Osteoporosis Research
- ClinicalTrials.gov ID
- NCT00154609
- Acronym / sponsor ID
- 930701
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal osteoporosis
Key exclusion criteria (1 listed)
- Insulin dependent diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gu-Sui-Bu (Davallia Divaricata) | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Hwa-Chang, Ph.D study chair
National Taiwan University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gu-Sui-Bu (Davallia Divaricata) in people with Osteoporosis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Hwa-Chang, Ph.D (886-2-23956988, hcliu@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2006.