Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-27 @ 12:07 PM
Study NCT ID:
NCT02885857
Status:
UNKNOWN
Last Update Posted:
2016-09-01
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583767', 'term': 'shenyan kangfu'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Routine blood test', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Routine urine test', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Liver function', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Renal function tests', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Potassium detection', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'blood glucose testing', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Electrocardiograph', 'timeFrame': 'Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times'}, {'measure': 'chest radiography', 'timeFrame': 'Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times'}, {'measure': 'Adverse events / adverse reactions', 'timeFrame': 'Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times', 'description': 'Follow-up 3 times.Subject at any time to contact your doctor.'}], 'primaryOutcomes': [{'measure': '24-hour urinary protein excretion', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Glomerular filtration rate', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Albumin', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}, {'measure': 'Glycated hemoglobin', 'timeFrame': 'Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times', 'description': 'Observations of the project value and the percentage change in value before and after the treatment.'}, {'measure': 'Symptom scores', 'timeFrame': 'Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.', 'detailedDescription': 'Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.\n\nThe crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.\n\nStudy design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosed with primary glomerulonephritis or diabetic nephropathy;\n2. Aged from 18 to 70 years，male or female\n3. GFR≥45ml/min/1.73㎡\n4. 0.5g≤24 hours proteinuria≤3.0g\n5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)\n6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency\n7. Obtain the agreement of patients or their guardians, and signed informed consent file\n\nExclusion Criteria:\n\n1. Secondary nephropathy\n2. People allergic to Shenyankangfu tables\n3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life\n4. Pregnant or lactating women\n5. Be participating in another clinical study at the same period"}, 'identificationModule': {'nctId': 'NCT02885857', 'briefTitle': 'Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'S2015-023-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shenyan kangfu Tablets', 'description': 'Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day', 'interventionNames': ['Drug: Shenyan Kangfu Tablet']}], 'interventions': [{'name': 'Shenyan Kangfu Tablet', 'type': 'DRUG', 'description': 'Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.', 'armGroupLabels': ['Shenyan kangfu Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jie wu, doctor', 'role': 'CONTACT', 'email': 'wujie301@163.com'}, {'name': 'xiangmei chen, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Guang'anmen Hospital, China Academy of Chinese Medical Sciences", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Daping Hospital,Research Institute of Surgery Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fuzhou General Hospital Nanjing Military Command', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'facility': "174th hospital of the People's Liberation Army", 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Qinhuangdao', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beidaihe Sanatorium of Beijing Military Mrca', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Heilongjiang University of Chinese Medicine', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': "Henan Provincial People'S Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Province Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Changhai Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'LONGHUA Hospital Shanghai University of TCM', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'First Teaching Hospital of Tianjin University of TCM', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jie Wu, chaieman', 'role': 'CONTACT', 'email': 'wujie301@126.com', 'phone': '18210128683'}, {'name': 'SiJi Li, director', 'role': 'CONTACT', 'email': 'miaoshujie@yeah.net', 'phone': '13821669488'}], 'overallOfficials': [{'name': 'YongLi Zhan, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, {'name': 'HongTao Yang, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Teaching Hospital of Tianjin University of Traditional Chinese Medicine'}, {'name': 'Meng Liang, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "174th hospital of the People's Liberation Army"}, {'name': 'Lu Ma, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beidaihe Sanatorium of Beijing Military Mrca'}, {'name': 'LiQun Song, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heilongjiang University of Chinese Medicine'}, {'name': 'QiaoLing Zhou, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiangya Hospital of Central South University'}, {'name': 'Ping Luo, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Hospital of Jilin University'}, {'name': 'RongShan Li, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanxi provincial peple's hospital"}, {'name': 'XiaoHong Cheng, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaanxi Traditional Chinese Medicine Hospital'}, {'name': 'Jie Wu, investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chen Xiangmei', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tianjin TongRenTang Group Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Chen Xiangmei', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}