[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100390801":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":27,"studyPopulation":20,"armGroups":28,"interventions":40,"overallOfficials":20,"centralContacts":20,"locations":47,"responsibleParty":71,"collaborators":20,"id":74,"slug":20,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":20,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Showa Inan General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change of computed tomography (CT) findings","Change of the intraluminal gas pockets in the colon on CT images before and after the administration of TJ-134","at enrollment and 8 weeks after the administration of TJ134",[14,17],{"measure":15,"description":16,"timeFrame":12},"Bloating and abdominal pain","Both bloating and abdominal pain are evaluated using visual analogue scale (VAS) score (0-100; 0, none).",{"measure":18,"description":19,"timeFrame":12},"Abdominal symptoms","Abdominal symptoms were evaluated on the Gastrointestinal Symptoms Rating Scale (GSRS) one a scale of 1 to5 (1 = none).",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE","1. Based on endoscopic finding, patients with symptomatic PCI are recruited.\n2. After enrollment, abdominal symptoms are evaluated and abdominal CT is performed.\n3. Patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional Japanese medicine or lactomin (control). Randomization was carried out by computer-generated random sequences.\n4. The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g\u002Fday), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g\u002Fday) is administered to enrolled patients for 8 weeks.\n5. After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"TJ-134 group","ACTIVE_COMPARATOR","The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g\u002Fday), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) is administered to enrolled patients for 8 weeks.",[34],"Drug: Japanese traditional medicine group",{"label":36,"type":37,"description":38,"interventionNames":39},"Lactomin group","PLACEBO_COMPARATOR","Lactomin (3g\u002Fday) is administered to enrolled patients for 8 weeks.",[34],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Japanese traditional medicine group","TJ-134 (7.5g\u002Fday) or lactomin (3g\u002Fday) is administered for 8 weeks.",[36,30],[36],[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Showa Inan General hospital","RECRUITING","Komagane","Nagano","399-4117","Japan","JP",{"type":57,"coordinates":58},"Point",[59,60],137.93745,35.71657,{"lat":60,"lon":59},[63,69],{"name":64,"role":65,"phone":66,"phoneExt":67,"email":68},"Akira Horiuchi, M.D.","CONTACT","81265822121","3012","horiuchi.akira@sihp.jp",{"name":64,"role":70,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Akira Horiuchi","Chief of Digestive Disease Center","100390801",false,"NCT04368663","The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis","The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides","Inclusion Criteria:\n\n* typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa\n\nExclusion Criteria:\n\n* patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）","ALL","18 Years","100 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"NA","The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (PCI) as compared with lactomin for 8 weeks.",[91],"Pneumatosis Cystoides Intestinalis",[91],"2025-05-14",{"date":95,"type":96},"2025-05-15","ACTUAL",{"date":98,"type":96},"2020-05-01",{"date":100,"type":85},"2026-12-31",{"name":5,"class":6},1]