Nctid:
NCT06231264
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003092", "term"=>"Colitis"}, {"id"=>"D000003093", "term"=>"Colitis, Ulcerative"}, {"id"=>"D000014456", "term"=>"Ulcer"}], "ancestors"=>[{"id"=>"D000005759", "term"=>"Gastroenteritis"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000003108", "term"=>"Colonic Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000015212", "term"=>"Inflammatory Bowel Diseases"}], "browseLeaves"=>[{"id"=>"M6320", "name"=>"Colitis", "asFound"=>"Colitis", "relevance"=>"HIGH"}, {"id"=>"M6321", "name"=>"Colitis, Ulcerative", "asFound"=>"Ulcerative Colitis", "relevance"=>"HIGH"}, {"id"=>"M17206", "name"=>"Ulcer", "asFound"=>"Ulcerative", "relevance"=>"HIGH"}, {"id"=>"M8875", "name"=>"Gastroenteritis", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M6336", "name"=>"Colonic Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M17917", "name"=>"Inflammatory Bowel Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T312", "name"=>"Tea", "asFound"=>"Oral administration", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Herbal and Botanical", "abbrev"=>"HB"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>96}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-19", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-21", "studyFirstSubmitDate"=>"2024-01-10", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-22", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Clinical response", "timeFrame"=>"8 weeks", "description"=>"decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1"}], "secondaryOutcomes"=>[{"measure"=>"Change from baseline in the Mayo score", "timeFrame"=>"8 weeks", "description"=>"Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome."}, {"measure"=>"Endoscopic remission", "timeFrame"=>"8 weeks", "description"=>"defined as Mayo endoscopic score ≤ 1"}, {"measure"=>"Clinical remission", "timeFrame"=>"8 weeks", "description"=>"overall score ≤2 \\[and no individual subscore \\>1\\]"}, {"measure"=>"Symptomatic remission", "timeFrame"=>"2, 4, 6, and 8 weeks", "description"=>"Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0"}, {"measure"=>"Fecal calprotectin", "timeFrame"=>"4 and 8 weeks", "description"=>"fecal sample"}, {"measure"=>"erythrocyte sedimentation rate", "timeFrame"=>"4 and 8 weeks", "description"=>"blood sample"}, {"measure"=>"C reactive protein", "timeFrame"=>"4 and 8 weeks", "description"=>"blood sample"}, {"measure"=>"pancreatic polypeptide", "timeFrame"=>"4 and 8 weeks", "description"=>"blood sample"}, {"measure"=>"norepinephrine", "timeFrame"=>"4 and 8 weeks", "description"=>"blood sample"}, {"measure"=>"acetyl choline", "timeFrame"=>"4 and 8 weeks", "description"=>"blood sample"}, {"measure"=>"acetyl choline", "timeFrame"=>"8 weeks", "description"=>"Intestinal mucosal tissue sample"}, {"measure"=>"alpha7 nicotinic acetylcholine receptor", "timeFrame"=>"8 weeks", "description"=>"Intestinal mucosal tissue sample"}, {"measure"=>"Inflammatory Bowel Disease Questionnaire Score", "timeFrame"=>"4 and 8 weeks", "description"=>"The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome"}, {"measure"=>"Hospital Anxiety and Depression scale score", "timeFrame"=>"4 and 8 weeks", "description"=>"anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome."}, {"measure"=>"Pittsburgh sleep quality index", "timeFrame"=>"4 and 8 weeks", "description"=>"The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome."}, {"measure"=>"autonomic profile characteristics", "timeFrame"=>"4 and 8 weeks", "description"=>"heart rate variability indicating sympathetic and parasympathetic activity"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Ulcerative Colitis"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age ≥18 years\n2. Ulcerative colitis diagnosed for at least 3 mouths.\n3. Mayo score 4-10, Mayo endoscopic score 2-3 points\n4. Resistant to at least one type of medical treatments\n\nExclusion Criteria:\n\n1. Treatment-naive ulcerative colitis (no previous treatment)\n2. Acute severe ulcerative colitis\n3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis\n4. Other systemic diseases\n5. Pregnancy and lactation\n6. Allergic to the electrode patch"}, "identificationModule"=>{"nctId"=>"NCT06231264", "briefTitle"=>"Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis", "organization"=>{"class"=>"OTHER", "fullName"=>"Xijing Hospital"}, "officialTitle"=>"A Multicenter Randomized Controlled Trial of Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis", "orgStudyIdInfo"=>{"id"=>"KY20232371"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"treatment group", "description"=>"Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks.", "interventionNames"=>["Device: transcutaneous electrical acustimulation at treatment sites"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"shame group", "description"=>"Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks.", "interventionNames"=>["Device: transcutaneous electrical acustimulation at sham sites"]}], "interventions"=>[{"name"=>"transcutaneous electrical acustimulation at treatment sites", "type"=>"DEVICE", "otherNames"=>["TEA"], "description"=>"A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the treatment site. The precise stimulating sites are not described upon registration to reduce unblinding risk.", "armGroupLabels"=>["treatment group"]}, {"name"=>"transcutaneous electrical acustimulation at sham sites", "type"=>"DEVICE", "otherNames"=>["sham-TEA"], "description"=>"A transcutaneous electrical stimulator (TEA) device applies a mild electric stimulation through the skin, similar to acupuncture at the sham treatment sites. The precise stimulating sites are not described upon registration to reduce unblinding risk.", "armGroupLabels"=>["shame group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"710000", "city"=>"Xi'an", "state"=>"Shaanxi", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Shuang Han", "role"=>"CONTACT"}], "facility"=>"Honghui hospital", "geoPoint"=>{"lat"=>34.25833, "lon"=>108.92861}}, {"zip"=>"710032", "city"=>"Xi'an", "state"=>"Shaanxi", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Sumei Sha", "role"=>"CONTACT"}], "facility"=>"Second Affiliated Hospital of Xi 'an Jiaotong University", "geoPoint"=>{"lat"=>34.25833, "lon"=>108.92861}}, {"zip"=>"710032", "city"=>"Xi'an", "state"=>"Shaanxi", "status"=>"NOT_YET_RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Ning Wang", "role"=>"CONTACT"}], "facility"=>"Tangdu Hospital", "geoPoint"=>{"lat"=>34.25833, "lon"=>108.92861}}, {"zip"=>"710032", "city"=>"Xi'an", "state"=>"Shaanxi", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Jian Wan", "role"=>"CONTACT", "email"=>"408127528@qq.com", "phone"=>"+8615529202305"}], "facility"=>"Xijing Hospital", "geoPoint"=>{"lat"=>34.25833, "lon"=>108.92861}}], "centralContacts"=>[{"name"=>"Jian Wan", "role"=>"CONTACT", "email"=>"408127528@qq.com", "phone"=>"+8615529202305"}], "overallOfficials"=>[{"name"=>"Kaichun Wu", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Xijing Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Xijing Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
