Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-02-09 @ 11:39 PM
Study NCT ID:
NCT02592161
Status:
COMPLETED
Last Update Posted:
2015-10-30
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of T-score of bone mineral density(QCT)', 'timeFrame': 'baseline, After 24 weeks(± 3 days) from the baseline of the trial'}], 'secondaryOutcomes': [{'measure': 'The change of T-score', 'timeFrame': 'baseline, After 4 weeks, 12 weeks from the baseline of the trial'}, {'measure': 'The change of osteoporosis-related indicators of blood tests', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}, {'measure': 'The change of ODI(Oswestry Disability Index)', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}, {'measure': 'The change of QVAS(Quardruple Visual Analog Scale)', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}, {'measure': 'The change of kupperman index', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}, {'measure': 'The change of shin-huh symptoms', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}, {'measure': 'The change of quality of life using SF-36', 'timeFrame': 'baseline, After 4 weeks, 12 weeks, 24 weeks(endpoint) from the baseline of the trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': "A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1)Female more than 50 years old in osteoporosis\n\nExclusion Criteria:\n\n1. Wash out peroid: using agents more than 3 months against osteoporosis\n2. Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)\n3. Subject who has a chronic liver disease, thyroid disease and chronic renal disease\n4. Subject who is chronic alcoholics and undernourished\n5. Other conditions were not suitable in study : Severe physical defects mental defects\n6. Pregnant woman\n7. Subject who is not calibrated hypercalcemia/hypocalcemia\n8. Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)\n9. Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)'}, 'identificationModule': {'nctId': 'NCT02592161', 'briefTitle': "Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis", 'nctIdAliases': ['NCT01771510'], 'organization': {'class': 'OTHER_GOV', 'fullName': 'Korea Health Industry Development Institute'}, 'officialTitle': "A Randomized, Single Center, Double Blind, Parallel, Placebo-controlled Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis", 'orgStudyIdInfo': {'id': 'B110051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks', 'interventionNames': ['Drug: Experimental']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'description': 'Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment) Three times a day, oral administration for 24weeks', 'interventionNames': ['Drug: Experimental']}], 'interventions': [{'name': 'Experimental', 'type': 'DRUG', 'otherNames': ['Chung A Won'], 'description': 'Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks\n\nReference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment)\n\nThree times a day, oral administration for 24weeks', 'armGroupLabels': ['Experimental', 'Placebo comparator']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Health Industry Development Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyun Lee', 'investigatorAffiliation': 'Korea Health Industry Development Institute'}}}}