Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
NCT ID: NCT00202956
Last Updated: 2005-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
2004-06-30
2005-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bugusan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients have bone mineral density \<-2.5 SD of T score at the lumbar spine (L2-L4);
3. All patients must sign the informed consent form (ICF) prior to the trial.
Exclusion Criteria
2. Any X-ray film that documents bone fracture within 3 month prior to the trial.
3. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;
4. Use of other Chinese medicine within 2 weeks prior to the trial;
5. Patients with significant renal function impairment (Creatinine\>2mg/dl) and liver function impairment (AST and ALT \> 2 x the upper limit of normal range);
6. Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;
7. Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);
8. Patients have life threatening disease;
9. Patients are allergic to any of the composition of Chinese medicine;
10. Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;
45 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taichung Veterans General Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huey-Herng Sheu
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Huey-Herng Sheu, Doctor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JL-HM-01-01
Identifier Type: -
Identifier Source: org_study_id