Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-04-03 @ 5:02 PM
Study NCT ID:
NCT02275468
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4
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': 'C000621460', 'term': 'fu-zheng-qu-zhuo'}, {'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite end point', 'timeFrame': '12 month after the treatmnet and 3 years of the follow up time', 'description': 'end stage renal disease (defined by the need for long-term dialysis or renal transplantation, or eGFR\\<15ml/min) and all cause of death'}], 'secondaryOutcomes': [{'measure': 'the slope of the eGFR versus observation time', 'timeFrame': '12 month after the treatment', 'description': 'the decline of eGFR per-year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'eGFR slope', 'Herbal medicine Fu-zheng-qu-zhuo Oral liquid'], 'conditions': ['Stage 3 Chronic Kidney Disease', 'Stage 4 Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'a prospective, multicenter (outpatient clinics of the three participating hospitals in Beijing), double blinded and randomized placebo-controlled study.\n\nThe study consisted of a 2-week run-in period and a 12-month treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Signed informed consent and aged from 18 to 75 years old. (2) Chronic renal diseases with Glomerular Filtration Rate (GFR) estimated using the CKD Epidemiology Collaboration (CKD-EPI) equation between 15 and 59 ml/min per 1.73 m2 on at least 2 dates separated by at least 90 days but no more than 6 month (the CKD defining window period). (3)Not received other TCM treatment for at least 2 weeks.\n\nExclusion Criteria:\n\n(1) 50% increase in serum creatinine occurring within 2 month before screening. (2) Immediate need for dialysis. (3) Myocardial infarction or cerebrovascular accident in the 6 month preceding the trial. (4) Connective-tissue disease, obstructive uropathy and renal transplantation. (5) Patients with severe disease in other organs or cancer, psychotic diseases, and active tuberculosis. (6) Treatment with corticosteroid and immunosuppressive agents in recent 3 month. Hemoglobin (Hb) less than 80 g/L. (7) Diabetes Mellitus with uncontrolled Blood Sugar ( glycated hemoglobin （HbA1c） \\>8.0%). (8) Enrolled in other trials. (9) Women in pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT02275468', 'briefTitle': 'Fu-zheng-qu-zhuo Oral Liquid Improves Renal Function in Patients of CKD Stage 3 and 4', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'Fu-zheng-qu-zhuo Oral Liquid Combined With Integrated Therapy Improves Renal Function in Patients of Chronic Kidney Disease Stage 3 and 4，a Randomized Placebo-Control Clinical Trial', 'orgStudyIdInfo': {'id': 'SF-2009-Ⅲ-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Patients of Control Group received FZQZ-Placebo 20ml every time, and three times a day combined with integrated therapy.The integrated therapy was as follows: (1)low-protein dietary with sufficient calorie supply.(2) Anti-hypertensive agents to achieve a systolic blood pressure of less than 140 mm Hg and a diastolic blood pressure of less than 90 mmHg.(3)Anti-hyperlipidemic agentsas necessary to achieve low-density lipoprotein cholesterol（LDL-CH）less than 2.6mmol/L and triglycerides less than1.7mmol/L.（4）Patients with Diabetes Mellitus received insulin or oral hypoglycemic agents to achieve HbA1c 6.5～8.0%. (5)Received Sodium Bicarbonate as necessary to achieve serum HCO3-≥22mmol/L.(6) Received ferrous succinate, folic acid, and erythropoietin to achieve HB 90\\~110g/L.'}, {'type': 'EXPERIMENTAL', 'label': 'Fu-zheng-qu-zhuo oral liquid Group', 'description': 'Patients of FZQZ Group received Fu-zheng-qu-zhuo (FZQZ) oral liquid 20ml every time, and three times a day combined with integrated therapy. The integrated therapy was same to Control Group.', 'interventionNames': ['Drug: Fu-zheng-qu-zhuo (FZQZ) oral liquid']}], 'interventions': [{'name': 'Fu-zheng-qu-zhuo (FZQZ) oral liquid', 'type': 'DRUG', 'otherNames': ['FZQZ oral liquid'], 'description': 'FZQZ oral liquid is a herbal medicine, composed of astragalus, angelica root, rhubarb, etc, with the effect of reinforcing Qi and activating blood, dissolving dampness and downbearing turbid.', 'armGroupLabels': ['Fu-zheng-qu-zhuo oral liquid Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Guang anmen Hospital, China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fangshan Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Guang'an Men Hospital South", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jie Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Guang anmen Hospital, China Academy of Chinese Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fangshan Hospital of Traditional Chinese Medicine,', 'class': 'OTHER'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}