Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT03563235
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002117', 'term': 'Calcitriol'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2018-05-31', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone density（BMD）', 'timeFrame': 'Xulin Jiangu treats for up to six months', 'description': 'BMD is the gold standard of oeteoporosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoporosis', 'kidney deficiency and blood stasis syndrome', 'Xuling Jiangu Granules'], 'conditions': ['Postmenopausal Osteoporoses']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a common senile disease with a high incidence. The Chinese medicine differentiation treatment has small side effects and can be taken for a long time, which has certain advantages. This project adopts the experience of the person in charge of the project-Xulin Jiangu Granules and clinically collects patients with postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome).', 'detailedDescription': 'Randomized control method was used to observe the clinical efficacy of the treatment of postmenopausal osteoporosis (kidney deficiency and blood stasis syndrome) with jiujian jiangu granules, combined with the gene expression of bone metabolism markers BALP, PINP, TRACP and S-CTX, and RANK, RANKL and OPG Detection, compared with the control group of ossification trihydrate capsules, to explore the mechanism of the treatment of postmenopausal osteoporosis by the continued Xulin Jiangu granules, and lay the foundation for the development of new drugs.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 2 years prior and met the diagnostic criteria for osteoporosis according to the "clinical practice guidelines of traditional medicine for primary osteoporosis\n* met the CM diagnostic criteria according to "Syndrome Differentiation in Modern Research of Traditional Chinese Medicine\n\nExclusion Criteria:\n\n* patients who did not meet the diagnostic criteria for osteoporosis or CM standards\n* patients with rheumatoid arthritis, diabetes, secondary osteoporosis due to hyperthyroidism, and severe cardiovascular or cerebrovascular diseases\n* patients with abnormal liver and/or Shen function test results\n* patients with osteoporosis who had received treatment with CM within the last month, hormone replacement therapy and calcitonin within the past three months, or bisphosphonates for 15 consecutive days within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03563235', 'acronym': 'CSOPOPWXJG', 'briefTitle': 'Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Academy of Traditional Chinese Medicine'}, 'officialTitle': 'Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules', 'orgStudyIdInfo': {'id': '2018R1035-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xulin Jiangu granules', 'description': 'Xulin Jiangu granule 15g tablet by mouth every 6 hour for 6 months', 'interventionNames': ['Drug: Xulin Jiangu granules', 'Drug: Calcitriol capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcitriol capsules', 'description': 'Calcitriol capsules tablets 0.25 ug by mouth every 6 hour for 6 months', 'interventionNames': ['Drug: Xulin Jiangu granules', 'Drug: Calcitriol capsules']}], 'interventions': [{'name': 'Xulin Jiangu granules', 'type': 'DRUG', 'description': 'Xulin Jiangu granules tablets', 'armGroupLabels': ['Calcitriol capsules', 'Xulin Jiangu granules']}, {'name': 'Calcitriol capsules', 'type': 'DRUG', 'description': 'Calcitriol capsules tablets', 'armGroupLabels': ['Calcitriol capsules', 'Xulin Jiangu granules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350003', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Academy of Trational Chiness Medicine', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Academy of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}