{ "FullStudy":{ "Rank":217984, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514266", "OrgStudyIdInfo":{ "OrgStudyId":"H-17419" }, "Organization":{ "OrgFullName":"Baylor College of Medicine", "OrgClass":"OTHER" }, "BriefTitle":"Effect of Curcumin on Lung Inflammation", "OfficialTitle":"Effect of Curcumin on Lung Inflammation" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2005" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2007", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2010", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 20, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 23, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Amir Sharafkhaneh", "ResponsiblePartyInvestigatorTitle":"Associate Professor of Medicine", "ResponsiblePartyInvestigatorAffiliation":"Baylor College of Medicine" }, "LeadSponsor":{ "LeadSponsorName":"Baylor College of Medicine", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"M.D. Anderson Cancer Center", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.\n\nCurcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Obstructive Pulmonary Disease" ] }, "KeywordList":{ "Keyword":[ "proven diagnosis", "COPD", "sputum" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"57", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Curcumin+bioprine", "ArmGroupType":"Experimental", "ArmGroupDescription":"The study involves active arm of Curcumin+Bioprine", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Curcumin+Bioprine" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Curcumin+Bioprine", "InterventionDescription":"The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Curcumin+bioprine" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in sputum dysplasia", "PrimaryOutcomeDescription":"We evaluated presence of moderate or worse dysplasia at baseline and each subsequent visits. The primary endpoint of this study is change in sputum cytological abnormality (moderate or worse dysplasia). The change will be comparison of 3-month follow up compared to baseline.", "PrimaryOutcomeTimeFrame":"3 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of subjects with adverse events in each arm of the study.", "SecondaryOutcomeTimeFrame":"3 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent\n20 pack year cigarette smoking\nStable clinical course (symptoms/ medications) for 8 weeks\nFixed address/Not planning to leave\nBeing able to perform spirometry\nAble to understand and consent\n\nExclusion Criteria:\n\nOther chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis\nHeart failure NYH III & IV; symptomatic liver or renal failure\nDementia or other neurocognitive deficit preventing completion of symptom diary\nUse of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"VA Medical Center", "LocationCity":"Houston", "LocationState":"Texas", "LocationZip":"77030", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000003474", "InterventionMeshTerm":"Curcumin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M5268", "InterventionBrowseLeafName":"Curcumin", "InterventionBrowseLeafAsFound":"Curcumin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008173", "ConditionMeshTerm":"Lung Diseases, Obstructive" },{ "ConditionMeshId":"D000029424", "ConditionMeshTerm":"Pulmonary Disease, Chronic Obstructive" },{ "ConditionMeshId":"D000011014", "ConditionMeshTerm":"Pneumonia" },{ "ConditionMeshId":"D000007249", "ConditionMeshTerm":"Inflammation" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000012141", "ConditionAncestorTerm":"Respiratory Tract Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12487", "ConditionBrowseLeafName":"Pneumonia", "ConditionBrowseLeafAsFound":"Lung Inflammation", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8876", "ConditionBrowseLeafName":"Inflammation", "ConditionBrowseLeafAsFound":"Inflammation", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafAsFound":"Obstructive Pulmonary Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M22033", "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive", "ConditionBrowseLeafAsFound":"Chronic Obstructive Pulmonary Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13561", "ConditionBrowseLeafName":"Respiratory Tract Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }