[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557198":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":39,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":20,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":20,"enrollmentInfo":51,"targetDuration":20,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":23,"whyStopped":20,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Hong Kong Baptist University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","During the 2-week intervention, all participants are required to take 150ml of SCD-2101 liquid (a Chinese herbal medicine formula containing four herbs) twice per day",[13],"Drug: SCD-2101",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","SCD-2101","Tradictional Chinese Medicine formula (SCD-2101)",[9],null,[22],{"facility":5,"status":23,"city":24,"state":20,"zip":20,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"RECRUITING","Kowloon Tong","Hong Kong","HK",{"type":28,"coordinates":29},"Point",[30,31],114.17969,22.33312,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":20,"email":38},"ZhaoXiang Bian, Prof.","CONTACT","85234116521","bzxiang@hkbu.edu.hk",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","ZhaoXiang Bian","Professor","100557198","a-single-arm-pilot-study-of-the-chinese-herbal-medicine-formula-scd-2101-for-the-functional-constipation-in-the-elderly-100557198",false,"NCT06534996","A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderly","Inclusion Criteria:\n\n* (1) Age ≥ 60 years old (2) Meet the Rome IV diagnostic criteria for functional constipation (3) Complete spontaneous bowel movements ≤ 2 times per week, to be assessed based on a 2-week electronic diary record (CSBMs are defined as the number of times within a 24-hour period that the patient can defecate spontaneously without the use of laxatives or enemas and feels that the stool is completely evacuated) (4) Have colonoscopy results with a diagnosis of no significant abnormalities seen or no more than 3 colorectal polyps, each less than 0.5 cm in size (based on results within the last 5 years before screening) (5) Understand and be able to follow written and oral instructions in Chinese (6) Capable of independently using WhatsApp and an electronic diary, and completing a 2-week electronic diary record during the screening period (7) The subject is informed and voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* (1) Secondary constipation (constipation caused by drugs or other diseases); (2) Currently using or requiring continued use of medications that may affect the outcomes of the trial (including but not limited to: antibiotics, hormonal drugs, analgesics, neurotransmitter drugs, gut flora-regulating medications, etc.); (3) Colonoscopy or sigmoidoscopy reveals clinically significant abnormalities; (4) Clinically significant abnormalities in laboratory tests or imaging examinations within the last 6 months; (5) History of allergy to traditional Chinese medicine; (6) History of abdominal surgery within the past year (except for laparoscopic appendectomy); (7) Patients with psychiatric diseases or those requiring the use of psychotropic drugs; (8) Deemed by the researchers as unsuitable to participate in this study for psychological or physical reasons.","ALL","60 Years",{"count":52,"type":53},14,"ESTIMATED","INTERVENTIONAL",[56],"NA","This single-arm, open-label pilot clinical trial will test the hypothesis that SCD-2101, a Chinese herbal medicine formula, will have efficacy in alleviating constipation in elderly individuals with functional constipation. All participants (n=14) will receive 2 weeks of intervention and 2 weeks of follow-up.",[59],"Functional Constipation",[61],"elderly, Chinese Herbal Medicine, Functional Constipation","2024-08-19",{"date":64,"type":65},"2024-08-20","ACTUAL",{"date":67,"type":65},"2024-08-01",{"date":69,"type":53},"2024-11-30",{"name":5,"class":6},1]