{ "FullStudy":{ "Rank":217681, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518218", "OrgStudyIdInfo":{ "OrgStudyId":"MOA-002" }, "Organization":{ "OrgFullName":"MOA Health Science Foundation", "OrgClass":"OTHER" }, "BriefTitle":"Effectiveness of Laying-on-of-hands for Sickle Cell Disease", "OfficialTitle":"Effectiveness of Laying-on-of-hands for Patients With Sickle Cell Disease in Africa" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"March 2007", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2009", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 21, 2012", "StudyFirstSubmitQCDate":"January 21, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 9, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 13, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Kiyoshi Suzuki", "ResponsiblePartyInvestigatorTitle":"president", "ResponsiblePartyInvestigatorAffiliation":"MOA Health Science Foundation" }, "LeadSponsor":{ "LeadSponsorName":"MOA Health Science Foundation", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to evaluate the effectiveness of 1-year administration of laying-on-of-hands on the morbidity and mortality of patients with sickle cell disease in Africa.", "DetailedDescription":"Patients with sickle cell disease (SCD) have a high risk of premature death in Africa, mainly due to insufficient medical services. SCD patients often visit emergency department and need hospitalization when they suffer from severe pain; however, they manage most of painful episodes at home. Appropriate pain management at home is, therefore, crucial to improve their clinical course and quality of life. Laying-on-of-hands may be a good candidate for home care management, because family member(s) can become a practitioner of laying-on-of-hands without difficulty and administer it to their loved one as an initial treatment whenever necessary. There are no reports concerning the effectiveness of laying-on-of-hands for the outcomes of SCD patients, as far as we have investigated." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sickle Cell Disease", "Pain Crisis Recurrent", "Anemia", "Infection", "Death" ] }, "KeywordList":{ "Keyword":[ "Sickle cell disease", "laying-on-of-hands", "morbidity", "mortality" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"laying-on-of-hands", "ArmGroupType":"Experimental", "ArmGroupDescription":"Patients of this arm received laying-on-of-hands twice a day (45 minutes each) every weekday for 1year, and received conventional medical treatment if necessary.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: laying-on-of-hands" ] } },{ "ArmGroupLabel":"control group", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Patients of this arm did not receive any alternatives other than conventional treatment." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"laying-on-of-hands", "InterventionDescription":"The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "laying-on-of-hands" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Okada Purifying Therapy", "biofield therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"disease-related episodes and mortality", "PrimaryOutcomeTimeFrame":"3 years and 9 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"blood data", "SecondaryOutcomeTimeFrame":"1 year" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\npatients with symptoms associated with sickle cell disease\nthose able to receive laying-on-of-hands every weekday for 1 year\nthose able to receive conventional medical treatment whenever necessary\nthose able to receive blood test at the beginning, after 6 month and after 1 year\n\nExclusion Criteria:\n\nthose who wish to use other complementary and alternative therapies along with laying-on-of-hands", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"3 Years", "MaximumAge":"40 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Kodondi K Koto, MD, PhD", "OverallOfficialAffiliation":"The Institute of Scientific Research for Health, Kinshasa", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The national medical center for sickle cell disease", "LocationCity":"Kinshasa", "LocationCountry":"Congo, The Democratic Republic of the" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"24445353", "ReferenceType":"derived", "ReferenceCitation":"Minga TM, Koto FK, Egboki H, Suzuki K. Effectiveness of biofield therapy for individuals with sickle cell disease in Africa. Altern Ther Health Med. 2014 Jan-Feb;20(1):20-6." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"MOA International Corporation", "SeeAlsoLinkURL":"http://www.moainternational.or.jp" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000000755", "ConditionMeshTerm":"Anemia, Sickle Cell" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000000745", "ConditionAncestorTerm":"Anemia, Hemolytic, Congenital" },{ "ConditionAncestorId":"D000000743", "ConditionAncestorTerm":"Anemia, Hemolytic" },{ "ConditionAncestorId":"D000000740", "ConditionAncestorTerm":"Anemia" },{ "ConditionAncestorId":"D000006402", "ConditionAncestorTerm":"Hematologic Diseases" },{ "ConditionAncestorId":"D000006453", "ConditionAncestorTerm":"Hemoglobinopathies" },{ "ConditionAncestorId":"D000030342", "ConditionAncestorTerm":"Genetic Diseases, Inborn" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2666", "ConditionBrowseLeafName":"Anemia, Sickle Cell", "ConditionBrowseLeafAsFound":"Sickle Cell Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2651", "ConditionBrowseLeafName":"Anemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5428", "ConditionBrowseLeafName":"Death", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2654", "ConditionBrowseLeafName":"Anemia, Hemolytic", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8130", "ConditionBrowseLeafName":"Hemolysis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M2656", "ConditionBrowseLeafName":"Anemia, Hemolytic, Congenital", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8122", "ConditionBrowseLeafName":"Hemoglobinopathies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M22270", "ConditionBrowseLeafName":"Genetic Diseases, Inborn", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T5256", "ConditionBrowseLeafName":"Sickle Cell Anemia", "ConditionBrowseLeafAsFound":"Sickle Cell Disease", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC16", "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }