Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT07032116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4472}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body temperature', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Body temperature'}, {'measure': 'blood pressure', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Both systolic and diastolic blood pressures should be measured.'}, {'measure': 'respiration', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years.', 'description': 'respiration'}, {'measure': 'heart rate', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'heart rate'}, {'measure': 'Number of participants with abnormal white blood cell count ( WBC )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal white blood cell count ( WBC )'}, {'measure': 'Number of participants with abnormal electrocardiogram', 'timeFrame': 'Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years', 'description': 'Number of participants with abnormal electrocardiogram'}, {'measure': 'glycosylated hemoglobin', 'timeFrame': 'Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years', 'description': 'glycosylated hemoglobin'}, {'measure': 'fasting blood glucose', 'timeFrame': 'Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years', 'description': 'fasting blood glucose'}, {'measure': 'incidence of adverse events', 'timeFrame': 'Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years', 'description': 'incidence of adverse events'}, {'measure': 'Number of participants with abnormal red blood cell count ( RBC )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal red blood cell count ( RBC )'}, {'measure': 'Number of participants with abnormal hemoglobin ( HGB )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal hemoglobin ( HGB )'}, {'measure': 'Number of participants with abnormal lymphocyte percentage ( LY % )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal lymphocyte percentage ( LY % )'}, {'measure': 'Number of participants with abnormal Percentage of neutrophils( NE % )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Percentage of neutrophils( NE % )'}, {'measure': 'Number of participants with abnormal Platelet count ( PLT )', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Platelet count ( PLT )'}, {'measure': 'Number of participants with abnormal Urine PH value', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urine PH value'}, {'measure': 'Number of participants with abnormal Urinary protein', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urinary protein'}, {'measure': 'Number of participants with abnormal Urine occult blood', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urine occult blood'}, {'measure': 'Number of participants with abnormal Urinary glucose', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urinary glucose'}, {'measure': 'Number of participants with abnormal Urine ketone', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urine ketone'}, {'measure': 'Number of participants with abnormal Urine white blood cells (high magnification field of view)', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urine white blood cells (high magnification field of view)'}, {'measure': 'Number of participants with abnormal Urine red blood cells (high magnification field of view)', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Urine red blood cells (high magnification field of view)'}, {'measure': 'Number of participants with abnormal Serum alanine aminotransferase', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum alanine aminotransferase'}, {'measure': 'Number of participants with abnormal Serum aspartate aminotransferase', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum aspartate aminotransferase'}, {'measure': 'Number of participants with abnormal Serum alkaline phosphatase', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum alkaline phosphatase'}, {'measure': 'Number of participants with abnormal Serum gamma-glutamyl transferase', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum gamma-glutamyl transferase'}, {'measure': 'Number of participants with abnormal Serum albumin (ALB)', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum albumin (ALB)'}, {'measure': 'Number of participants with abnormal Serum total bilirubin（TBIL）', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum total bilirubin（TBIL）'}, {'measure': 'Number of participants with abnormal Serum direct bilirubin（DBIL）', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum direct bilirubin（DBIL）'}, {'measure': 'Number of participants with abnormal Serum indirect bilirubin（IBIL）', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Number of participants with abnormal Serum indirect bilirubin（IBIL）'}, {'measure': 'Serum urea', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Serum urea'}, {'measure': 'Serum urate', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Serum urate'}, {'measure': 'Serum cystatin C', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Serum cystatin C'}, {'measure': 'Serum creatinine', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Serum creatinine'}, {'measure': 'Plasma triglyceride', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Plasma triglyceride'}, {'measure': 'Plasma high-density lipoprotein', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Plasma high-density lipoprotein'}, {'measure': 'Plasma total cholesterol', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Plasma total cholesterol'}, {'measure': 'Plasma low-density lipoprotein', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Plasma low-density lipoprotein'}], 'primaryOutcomes': [{'measure': 'The incidence of end-stage renal disease', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'dialysis, transplantation or glomerular filtration rate ( eGFR ) \\< 15ml / ( min · 1.73m2 )'}], 'secondaryOutcomes': [{'measure': 'Incidence of renal composite outcome indicators', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'End-stage renal disease \\[ dialysis, transplantation or glomerular filtration rate ( eGFR ) \\< 15ml / ( min · 1.73m2 ) \\], eGFR decreased by more than 50 %, renal causes of death were defined.'}, {'measure': 'Changes of urinary protein creatinine ratio', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Changes of urinary protein creatinine ratio'}, {'measure': 'Changes of 24-hour urinary protein level', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Changes of 24-hour urinary protein level'}, {'measure': 'Estimate the change value of glomerular filtration rate ( eGFR ) level, slope', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': 'Estimate the change value of glomerular filtration rate ( eGFR ) level, slope'}, {'measure': 'Chinese medicine syndrome scores', 'timeFrame': 'Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years', 'description': "The TCM（Traditional Chinese Medicine） symptoms of the patients were scored by the TCM syndrome scale in order to judge the improvement of their symptoms.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Kidney Disease (DKD)']}, 'descriptionModule': {'briefSummary': 'In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic kidney disease patients, in line with the inclusion criteria, do not meet the exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;\n* 2 18-80 years old, regardless of gender ;\n* 3 eGFR \\> 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).\n* 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;\n* 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;\n* 6 blood pressure ≤ 160 / 100mmHg ;\n* 7 to sign the informed consent ;\n\nExclusion Criteria:\n\n* 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;\n* 2 patients with a history of recurrent genitourinary tract infection ;\n* 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;\n* 4 currently in pregnancy, lactation, or pregnancy plan women ;\n* 5 Patients with type 1 diabetes.\n* 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.'}, 'identificationModule': {'nctId': 'NCT07032116', 'briefTitle': 'YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1', 'organization': {'class': 'OTHER', 'fullName': 'Dongzhimen Hospital, Beijing'}, 'officialTitle': 'Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 1', 'orgStudyIdInfo': {'id': '2023ZD0509303-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exposed group', 'description': 'People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect'}, {'label': 'Non-exposed group', 'description': 'Diabetic kidney disease patients who did not receive exposure factors.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Qingqing Liu', 'role': 'CONTACT', 'email': '125982343@qq.com', 'phone': '+8615811362511'}], 'facility': 'Dongzhimen Hospital of BeijingUniversity of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Shen Li', 'role': 'CONTACT', 'email': 'Lishen58173@163.com', 'phone': '+8613681116668'}], 'facility': "Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Wei Chen', 'role': 'CONTACT', 'email': 'chenwei99@mail.sysu.edu.cn', 'phone': '+8613924150966'}], 'facility': 'The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Jia Mi', 'role': 'CONTACT', 'email': 'mijia8201@126.com', 'phone': '+8613630558296'}], 'facility': 'The Affiliated Hospital to ChangChun University of Chinese Medicinecancel', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Baocheng Chang', 'role': 'CONTACT', 'email': 'changbc1970@126.com', 'phone': '+8618622051556'}], 'facility': 'Tianjin Medical University Chu Hsien-I Memorial Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Qingqing Liu', 'role': 'CONTACT', 'email': '125982343@qq.com', 'phone': '+8615811362511'}, {'name': 'Fengyi Cai', 'role': 'CONTACT', 'email': 'cfy201802@163.com', 'phone': '+8618810623691'}], 'overallOfficials': [{'name': 'HongFang Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dongzhimen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liu Hongfang', 'class': 'OTHER'}, 'collaborators': [{'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Tianjin Medical University Chu Hsien-I Memorial Hospital', 'class': 'UNKNOWN'}, {'name': 'Changchun University of Chinese Medicine', 'class': 'OTHER'}, {'name': 'EFONG PHARMRCEUTICRL', 'class': 'UNKNOWN'}, {'name': 'Xinxiang Central Hospital of Henan province', 'class': 'UNKNOWN'}, {'name': 'Xiamen Hospital of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Liaoning University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine', 'class': 'OTHER'}, {'name': 'Hubei Zhongshan Hospital Affiliated to Wuhan University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Liu Hongfang', 'investigatorAffiliation': 'Dongzhimen Hospital, Beijing'}}}}