Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT00895167
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2009-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs', 'timeFrame': '48 hrs'}], 'secondaryOutcomes': [{'measure': 'Increase of plasma bilirubin level', 'timeFrame': '48 hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heme Oxygenase', 'Genetic Polymorphism', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.meduniwien.ac.at/klpharm/', 'label': 'Department of Clinical Pharmacology of the Medical University of Vienna'}]}, 'descriptionModule': {'briefSummary': 'Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region will be investigated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent prior to any study-mandated procedure.\n* Male patient aged between 18 and 45 years (inclusive) at screening.\n* No clinically significant findings on the physical examination at screening.\n* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.\n* 12-lead ECG without clinically relevant abnormalities at screening.\n* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.\n* Negative results from urine drug screen at screening.\n* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Known hypersensitivity to the study drug or any excipients of the drug formulation.\n* Treatment with another investigational drug within 3 weeks prior to screening.\n* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.\n* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.\n* Smoking within the last 3 months prior to screening.\n* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.\n* Regularly intake of curcumin rich food\n* Loss of 250 ml or more of blood within 3 months prior to screening.\n* Positive results from the hepatitis serology, except for vaccinated subjects, at screening.\n* Positive results from the HIV serology at screening.\n* Presumed non-compliance.\n* Legal incapacity or limited legal capacity at screening."}, 'identificationModule': {'nctId': 'NCT00895167', 'acronym': 'CUMAHS', 'briefTitle': 'The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'EudraCT - 2008-004900-30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curcumin', 'description': 'every subject receives 12 g of oral curcumin', 'interventionNames': ['Dietary Supplement: curcumin']}], 'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Curcumin C3 Complex caplets containing:', '1000 mg curcumin and 5 mg bioperine', 'Lot. Nr.: #BA 08072227'], 'description': 'one oral dose of 12 caplets = 12 g curcumin', 'armGroupLabels': ['curcumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel Doberer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Subinvestigator', 'investigatorFullName': 'Daniel Doberer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}