Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-13 @ 2:14 PM
Study NCT ID:
NCT04934059
Status:
UNKNOWN
Last Update Posted:
2021-06-22
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], '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': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual analogue scale (VAS) for night pain', 'timeFrame': 'Baseline, at day 7, day 14, day 28, day 42 during treatment'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale (VAS) for whole day', 'timeFrame': 'Baseline, at day 7, day 14, day 28, day 42 during treatment'}, {'measure': 'BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)', 'timeFrame': 'Baseline, at day 28, day 42 during treatment'}, {'measure': 'BASFI (Bath Ankylosing Spondylitis Functional Index)', 'timeFrame': 'Baseline, at day 28, day 42 during treatment'}, {'measure': 'BASMI (Bath Ankylosing Spondylitis Metrology Index)', 'timeFrame': 'Baseline, at day 28, day 42 during treatment'}, {'measure': 'Syndrome score of traditional Chinese medicine', 'timeFrame': 'Baseline, at day 28, day 42 during treatment', 'description': 'The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).'}, {'measure': 'SF-36 (The Medical Outcomes Study 36-item short-form health survey)', 'timeFrame': 'Baseline, at day 42 during treatment'}, {'measure': 'ESR (Erythrocyte Sedimentation Rate)', 'timeFrame': 'Baseline, at day 14, day 28, day 42 during treatment'}, {'measure': 'CRP (C-Reactive Protein)', 'timeFrame': 'Baseline, at day 14, day 28, day 42 during treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ages 18-65, male or female\n2. Confirmed diagnosis of Ankylosing Spondylitis\n3. Syndrome of traditional Chinese medicine is blood stasis syndrome\n4. ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)≥2.1\n5. Visual analogue scale (VAS) for night pain≥4分\n6. Maintained stable doses of Sulfasalazine, Methotrexate, Leflunomide, etc. for more than 1 month if treating with Slow-Acting Antirheumatic Drugs\n7. Maintained stable doses of biologics for more than 3 month if treating with biologics\n8. Not use Nonsteroidal Antiinflammatory Drugs within 2 weeks\n9. Patients who have not participated in other clinical trials within 4 weeks\n10. Written informed consent\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding or who expecting to conceive\n2. Psoriatic arthritis or Enteropathic arthritis\n3. AS with iritis or uveitis\n4. Abnormal liver function\n5. Abnormal kidney function，high level of Creatinine\n6. WBC (White Blood Cell)\\<3.0×10\\^9/L or with Hematological Disease\n7. Patients with poor control of hypertension or diabetes\n8. Acute or chronic infectious diseases\n9. Severe arrhythmia\n10. Patients with malignant tumors or with a history of malignant tumors\n11. Drug allergy\n12. Patients who had taken Yuxuebi tablet for more than 4 weeks with poor outcome\n13. Patients who are treating with Traditional Chinese medicine for promoting blood circulation and removing blood stasis\n14. Alcohol or drug abuse\n15. Participants who are not suitable for clinical trial under doctors' consideration."}, 'identificationModule': {'nctId': 'NCT04934059', 'briefTitle': 'Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).', 'organization': {'class': 'INDUSTRY', 'fullName': 'China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.', 'orgStudyIdInfo': {'id': '2020005P8A02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yuxuebi tablet', 'description': 'take 5 tablets once, 3 times a day, for 42（±3）days.', 'interventionNames': ['Drug: Yuxuebi tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo tablet', 'description': 'take 5 tablets once, 3 times a day, for 42（±3）days.', 'interventionNames': ['Drug: Placebo tablet']}], 'interventions': [{'name': 'Yuxuebi tablet', 'type': 'DRUG', 'description': '0.5g/ tablet', 'armGroupLabels': ['Yuxuebi tablet']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': '0.5g/ tablet', 'armGroupLabels': ['Placebo tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Quan Jiang', 'role': 'CONTACT'}], 'facility': "Guang'anmen Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'contacts': [{'name': 'Xiaoyan Cai', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Guangzhou", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Jinzhong', 'country': 'China', 'contacts': [{'name': 'Tao Jiang', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Jinzhong", 'geoPoint': {'lat': 37.68403, 'lon': 112.75471}}, {'city': 'Nanchong', 'country': 'China', 'contacts': [{'name': 'Shiquan Shuai', 'role': 'CONTACT'}], 'facility': 'Nanchong Central Hospital', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}, {'city': 'Shenzhen', 'country': 'China', 'contacts': [{'name': 'Jianyong Zhang', 'role': 'CONTACT'}], 'facility': 'Shenzhen Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}