[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651933":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":47,"collaborators":26,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Mental Health Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","Xingqi Daozhi Decoction Group",[13],"Drug: Xingqi Daozhi Decoction",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Placebo Group",[19],"Drug: Placebo Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Xingqi Daozhi Decoction","Participants assigned to this arm will receive Xingqi Daozhi Decoction granules twice daily for 8 weeks. One packet will be taken each time, approximately 30 minutes after breakfast and dinner. The formulation contains Cistanche deserticola 30 g, Magnolia officinalis 15 g, Raphanus sativus seed 15 g, and Areca catechu pericarp 10 g. Participants will be monitored for constipation symptoms, bowel movements, psychiatric symptoms, safety, and adverse events throughout the treatment period",[9],null,{"type":22,"name":17,"description":28,"armGroupLabels":29,"otherNames":26},"Participants assigned to this arm will receive Xingqi Daozhi Decoction placebo granules twice daily for 8 weeks. The placebo contains 1\u002F10 of the active ingredients of Xingqi Daozhi Decoction, together with food-grade coloring, bittering agents, and lactose, and is matched to the active treatment in appearance, dosage, and administration. One packet will be taken approximately 30 minutes after breakfast and dinner.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Lanying L","CONTACT","13516816012","balindaliu@126.com",[37],{"facility":5,"status":26,"city":38,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Shanghai","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},{"type":48,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100651933","phase-1-xingqi-daozhi-decoction-for-antipsychotic-induced-constipation-100651933",false,"NCT07767526","Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation","A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern","XQD-AIC","Inclusion Criteria:\n\nMeets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia.\n\nPositive and Negative Syndrome Scale (PANSS) total score ≤95, with a PANSS negative symptom subscale score ≤28.\n\nMeets the Rome IV diagnostic criteria for functional constipation with a qi stagnation pattern.\n\nAged 18 to 65 years. Has at least a junior high school education and is able to complete self-report questionnaires.\n\nHas not used other medications known to cause constipation within the past 3 months.\n\nHas had no history of constipation within the past 2 years and no previous gastrointestinal disease.\n\nDeveloped constipation after initiation of antipsychotic medication.\n\nExclusion Criteria:\n\nMeets DSM-5 diagnostic criteria for any psychiatric disorder other than schizophrenia.\n\nIs unable to maintain a normal diet because of psychiatric symptoms, or requires a special diet such as a diabetic diet, soft diet, liquid diet, fasting, or restriction of oral intake due to individual clinical circumstances.\n\nUses other medications that may cause or aggravate constipation. Has had constipation within the past 2 years or has a history of gastrointestinal disease.\n\nHas lactose intolerance. Has clinically significant medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.\n\nIs pregnant, planning pregnancy in the near future, or breastfeeding.","ALL","18 Years","65 Years",{"count":61,"type":62},46,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","Antipsychotic medications are widely used to treat schizophrenia but may cause constipation, which can lead to abdominal discomfort, reduced quality of life, and poor treatment adherence. Xingqi Daozhi Decoction is a traditional Chinese medicine formula used to relieve constipation associated with qi stagnation. This study aims to evaluate the effectiveness and safety of Xingqi Daozhi Decoction for antipsychotic-induced constipation with a qi stagnation pattern.\n\nThis is a single-center, randomized, double-blind, placebo-controlled exploratory study. A total of 46 participants with schizophrenia who developed constipation after taking antipsychotic medications will be enrolled. Participants will be randomly assigned to receive either Xingqi Daozhi Decoction granules or matching placebo granules twice daily for 8 weeks. Neither the participants nor the treating clinicians and outcome assessors will know the treatment assignment during the study.\n\nParticipants will be evaluated regularly during treatment. The study will assess changes in bowel movements, constipation symptoms, constipation-related quality of life, and treatment safety. Participants will also undergo routine clinical and laboratory safety assessments, and adverse events will be recorded throughout the study. The primary outcome focuses on the proportion of participants who achieve an improvement in complete spontaneous bowel movements during treatment.",[69,70],"Schizophrenia","Antipsychotic Drug",[69,23,72,73,74],"Constipation","Antipsychotic drug","Traditional Chinese Medicine","NOT_YET_RECRUITING","2026-08-12",{"date":78,"type":79},"2026-08-17","ACTUAL",{"date":81,"type":62},"2026-10-01",{"date":83,"type":62},"2028-12-31",{"name":5,"class":6},1]