Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT02610595
Status:
UNKNOWN
Last Update Posted:
2015-11-20
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Therapeutic Effect of TCM Treatment for MDR MN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015433', 'term': 'Glomerulonephritis, Membranous'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate of 24 hours urinary protein quantitative', 'timeFrame': 'two weeks to three months'}], 'secondaryOutcomes': [{'measure': 'Renal function, glomerular filtration rate (EPI formula), Plasma albumin', 'timeFrame': 'two weeks to three months'}, {'measure': 'Blood lipid', 'timeFrame': 'half a year'}, {'measure': 'Change of TCM Syndrome', 'timeFrame': 'two weeks to three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Idiopathic Membranous Nephropathy', 'Jianpiyiqi Recipe', 'Huoxuejiedu Recipe', 'Effectiveness', 'Safety'], 'conditions': ['Idiopathic Membranous Nephropathy']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe.', 'detailedDescription': 'Based on previous research, the investigators hoping to identity the standard treatment program for MDR IMN patients with high treatment difficulty, TCM syndrome of s Pixushuifan. Subsequently, to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. With twenty national-grade III hospital of to formed TCM Comprehensive treatment plan and to evaluate the effectiveness and safety of the Chinese medicine treatment for multiple drug resistance of MN patients with Jianpiyiqi and Huoxuejiedu Recipe. Furthermore, search for potential diagnostic predictor in IMN by Proteomics and Metabolomics. The investigators purpose is improve the clinical remission rate of MN, further establish the treatment of TCM in the treatment of MN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years;\n2. Gender, nationality;\n3. Pixushuifan syndrome, IMN confirmed by renal biopsy and clinical examination;\n4. Treatment invalided by two or more than two kinds of Hormone or immunosuppressive agents ;\n5. CKD phase 1-3（eGFR（EPI Formula）≥30ml/min/1.73m2）\n\nExclusion Criteria:\n\n1. Progressive MN (progressive renal impairment, renal biopsy confirmed Necrotic Vasculitis and Large crescent formation\\>50%), combined with IgA nephropathy, diabetic nephropathy and other renal diseases;\n2. Anti-nuclear antibodies, double stranded DNA, ANCA or other indicators of immune disorders;\n3. Active hepatitis B and liver function test sustained abnormal;\n4. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases;\n5. Merger with other serious disease and dysfunction of the organ;\n6. Gravid or lactation woman;\n7. Other clinical trials are being studied.'}, 'identificationModule': {'nctId': 'NCT02610595', 'briefTitle': 'Study on the Therapeutic Effect of TCM Treatment for MDR MN', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'A Prospective, Multi-center Study of the Chinese Medicine for the Treatment of MDR Membranous Nephropathy in the Traditional Chinese Medicine (a Herbal Formula for Invigorating Spleen and Benefiting qi and Promoting Blood Circulation)', 'orgStudyIdInfo': {'id': 'ZY3-CCCX-3-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'Jianpixiaozhong particles and Wuse Dietotherapy', 'interventionNames': ['Drug: Jianpixiaozhong particles and Wuse Dietotherapy']}], 'interventions': [{'name': 'Jianpixiaozhong particles and Wuse Dietotherapy', 'type': 'DRUG', 'description': 'Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'YueYI Deng, Dr.', 'role': 'CONTACT', 'email': 'lhkidney@hotmail.com', 'phone': '64385700', 'phoneExt': '3222'}], 'facility': 'Department of Nephrology,Longhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yueyi Deng, MD.', 'role': 'CONTACT', 'email': 'dengyueyi@medmail.com.cn', 'phone': '+86-021-64385700-3226'}, {'name': 'Wanjia Chen, MS.', 'role': 'CONTACT', 'email': 'wdgzkj@sina.com', 'phone': '+86-021-64385700-3222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Putuo District Center Hospital', 'class': 'OTHER'}, {'name': 'ShuGuang Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Yueyang Integrated Medicine Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Minhang Central Hospital', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, {'name': 'Guangxi Traditional Chinese Medical University', 'class': 'OTHER'}, {'name': 'Huashan Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, {'name': 'Nanjing University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}