Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT00202956
Status:
UNKNOWN
Last Update Posted:
2005-09-20
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-05'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.', 'detailedDescription': 'The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values \\< 20 pg/ml, serum FSH values ≧ 25 mIU/mL;\n2. Patients have bone mineral density \\<-2.5 SD of T score at the lumbar spine (L2-L4);\n3. All patients must sign the informed consent form (ICF) prior to the trial.\n\nExclusion Criteria:\n\n1. Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;\n2. Any X-ray film that documents bone fracture within 3 month prior to the trial.\n3. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;\n4. Use of other Chinese medicine within 2 weeks prior to the trial;\n5. Patients with significant renal function impairment (Creatinine\\>2mg/dl) and liver function impairment (AST and ALT \\> 2 x the upper limit of normal range);\n6. Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;\n7. Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);\n8. Patients have life threatening disease;\n9. Patients are allergic to any of the composition of Chinese medicine;\n10. Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;"}, 'identificationModule': {'nctId': 'NCT00202956', 'briefTitle': 'Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects on Biomarkers and Safety of Bugusan (BGS) in Postmenopausal Patients With Osteoporosis.', 'orgStudyIdInfo': {'id': 'JL-HM-01-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bugusan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Huey-Herng Sheu, Doctor', 'role': 'CONTACT', 'email': 'whhsheu@vghtc.gov.tw', 'phone': '886-4-2359-2525', 'phoneExt': '4004'}, {'name': 'Huey-Herng Sheu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Huey-Herng Sheu', 'role': 'CONTACT', 'email': 'whhsheu@vghtc.gov.tw', 'phone': '8860402359-2525', 'phoneExt': '4004'}], 'overallOfficials': [{'name': 'Huey-Herng Sheu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}}}}