Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-01 @ 9:16 AM
Study NCT ID:
NCT01831193
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-23', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in proteinuria', 'timeFrame': '8 weeks'}]}, 'conditionsModule': {'conditions': ['Proteinuria']}, 'referencesModule': {'references': [{'pmid': '37916745', 'type': 'DERIVED', 'citation': 'Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the oral supplementation with curcumin reduces proteinuria in patients with chronic kidney disease regardless the ethiology.', 'detailedDescription': 'Curcumin is a potent antioxidant found in extracts of the rhizome of the plant Curcuma longa L.\n\nDifferent studies have demonstrated that curcumin has potent biological activity and therefore is an effective therapeutic agent for the treatment of various ailments.\n\nThis compound acts as a bifunctional antioxidant:\n\nه is capable of reacting directly with highly reactive oxygen species. ه acts indirectly by its ability to induce the expression of various cytoprotective proteins through Keap1/Nrf2/ARE pathway.\n\nAlthough RAAS blockade is the cornerstone to prevent the progression of proteinuric nephropathy, a significant number of patients remained with proteinuria and progress to end-stage renal disease.\n\nDue to the low cost and few side effects of curcumin, this could become an adjuvant treatment of proteinuric nephropathy purposes attenuate the progression of chronic kidney disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of proteinuric chronic kidney disease with 1g or more of proteins in a daily recollection.\n* Individuals taking Angiotensin II Receptor Blocker or ACE inhibitors in monotherapy with maximum dose or in combination.\n\nExclusion Criteria:\n\n* Hepatic damage.\n* Malignancy.\n* Pregnancy.\n* Peritoneal or hemodialysis.\n* Organ transplantation.\n* Heart failure classification III or IV (New York Heart Association).\n* History of chemotherapy within 2 years prior to screening.'}, 'identificationModule': {'nctId': 'NCT01831193', 'briefTitle': 'Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cardiologia Ignacio Chavez'}, 'officialTitle': 'Effect of Oral Supplementation With Curcumin (Turmeric) in Patients With Proteinuric Chronic Kidney Disease', 'orgStudyIdInfo': {'id': '12-793'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diabetic', 'interventionNames': ['Drug: Curcumin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-diabetic', 'interventionNames': ['Drug: Curcumin']}], 'interventions': [{'name': 'Curcumin', 'type': 'DRUG', 'otherNames': ['Turmeric'], 'armGroupLabels': ['Diabetic', 'Non-diabetic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cardiologia Ignacio Chavez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Magdalena Madero', 'investigatorAffiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez'}}}}