[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibs-diarrhea-predominant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibs-diarrhea-predominant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100638390","phase-3-phase-iii-clinical-trial-of-changjian-capsules-in-the-treatment-of-irritable-bowel-syndrome-with-predominant-diarrhea-liver-qi-invading-spleen-syndrome-100638390",false,"NCT07610434","Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)","Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)","Inclusion Criteria:\n\n1. Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome;\n2. Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen;\n3. Aged ≥18 and ≤65 years, regardless of gender;\n4. Record daily the most severe abdominal pain, bloating, and abdominal discomfort NRS scores for the last week of the run-in period. At least one of these three items must meet the weekly average NRS score criterion (the weekly average of abdominal pain NRS is calculated as: total weekly score of abdominal pain NRS on days with Bristol Stool Form Scale type 6 or 7 stools \u002F actual number of days with Bristol type 6 or 7 stools in that week; the average values for the other two items are calculated similarly) ≥3 points (11-point Numerical Rating Scale, NRS-11); meanwhile, for stool form, during the last week of the run-in period, there must be at least 2 days in which each day has at least one bowel movement of Bristol type 6 or 7;\n5. Self-Rating Anxiety Scale (SAS) \\\u003C60 points and Self-Rating Depression Scale (SDS) \\\u003C63 points;\n6. Have a colonoscopy result showing no obvious abnormalities (including diverticula or chronic inflammation) or colon polyps, based on colonoscopy results within 12 months prior at a tertiary hospital: 1.Colonoscopy results are normal with no organic changes; 2. Colonoscopy report shows minor abnormalities such as hemorrhoids or colonic polyps (diameter ≤5mm and number ≤3), which the investigator deems eligible for inclusion; 3. Previous colonoscopy reported colonic polyps with diameter \\>5mm or number \\>3, but after endoscopic treatment within 6 months prior to screening, remaining polyps are ≤5mm in diameter and ≤3 in number, deemed eligible by the investigator;\n7. Agree to participate in this clinical trial and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Individuals with fewer than 3 spontaneous bowel movements per week during the induction period;\n2. Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period;\n3. Individuals confirmed to have infectious diarrhea, inflammatory bowel disease, parasitic infection, positive fecal occult blood tests and considered to have gastrointestinal bleeding (excluding hemorrhoids), colorectal tumors, malabsorption syndrome, lactose intolerance (based on medical history), and diarrhea caused by systemic diseases;\n4. Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening;\n5. Individuals with non-IBS-D or other organic gastrointestinal lesions (excluding superficial gastritis, grade I erosive gastritis, or chronic atrophic gastritis found on endoscopy but deemed by the investigator to be eligible for inclusion (e.g., no mucosal erosion or bleeding observed endoscopically, and the patient has no upper abdominal fullness, upper abdominal pain, or acid reflux)), or other organic lesions that the investigator judges may cause abdominal pain, bloating, or discomfort;\n6. Individuals with diabetes, hyperthyroidism, or serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, or other serious diseases affecting survival (e.g., tumors), abnormal liver and kidney function (AST, ALT \\> 1.5 times the upper limit of normal reference range, Scr above the upper limit of normal reference range), and clinically significant ECG abnormalities;\n7. Individuals with other mental disorders (excluding mild anxiety or depression);\n8. Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal);\n9. Individuals who, within 2 weeks prior to screening, are using or need to continue using medications that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal drugs, antacids, prokinetic drugs, antidepressants (fluoxetine for at least 28 days), anti-anxiety drugs, intestinal microbiota regulators, traditional Chinese medicine decoctions, etc.);\n10. Individuals allergic to 3 or more medications or foods, or known allergies to Xiangjie Capsules and its components, as well as emergency medication Pivabromium tablets;\n11. Individuals who took emergency medication (Pivabromium tablets) during the last week of the induction period;\n12. Individuals who took prohibited medications during the induction period;\n13. Individuals suspected of or confirmed with a history of alcohol or drug abuse;\n14. Pregnant women, breastfeeding women, or women of childbearing age planning to conceive; or female participants of childbearing potential and male participants (whose partners are women of childbearing potential) who do not agree to voluntarily use effective contraception from screening to 3 months after the last dose;\n15. Individuals with cognitive impairment unable to provide fully informed consent;\n16. Individuals positive for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or syphilis treponemal antibody;\n17. Individuals who have participated in another clinical trial within the past month;\n18. Individuals known to have familial colorectal cancer syndrome;\n19. Individuals who, in the opinion of the investigator, have other factors making them unsuitable for inclusion.","ALL","18 Years","65 Years",{"count":20,"type":21},636,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trial. Its purpose is to evaluate the efficacy and safety of Changji'an Capsules in subjects with diarrhea-predominant irritable bowel syndrome (liver-qi invading spleen syndrome) after 8 weeks of treatment.",[27],"IBS, Diarrhea Predominant","NOT_YET_RECRUITING","2026-05-22",{"date":31,"type":32},"2026-05-28","ACTUAL",{"date":34,"type":21},"2026-05-31",{"date":36,"type":21},"2028-05-31",{"name":38,"class":39},"Beijing Hospital of Traditional Chinese Medicine","OTHER",29,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100625631","transcutaneous-electrical-acustimulation-for-ibs-d-a-multicenter-study-100625631","NCT07425145","Transcutaneous Electrical Acustimulation for IBS-D: A Multicenter Study","Transcutaneous Electrical Acustimulation (TEA) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Sham-Controlled Trial","Inclusion Criteria:1)Adults aged 18-65 years of either sex. 2)Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) will according to modified Rome IV criteria based on Asian consensus4: recurrent abdominal pain or discomfort (an unpleasant or bothersome sensation that is not described by the patient as pain, including fullness, bloating, or pressure), on average, at least 1 day per week in the last 3 months, associated with two or more of the following-related to defecation, associated with a change in stool frequency, or associated with a change in stool form-with symptom onset at least 6 months before diagnosis.\n\n3)Mean daily abdominal pain score (APS) or abdominal discomfort score (ADS) ≥ 3 on a 0-10 Numerical Rating Scale (NRS) in the last week.\n\n4)Type 6 or 7 of the Bristol Stool Form Scale (BSFS) appeared for at least 2 days in the last weeks.\n\n5)Colonoscopy performed within the past 3 years without evidence of organic gastrointestinal disease. Patients with colonic polyps or colonic diverticula may be included, provided there are no related complications.\n\n6)Willingness and ability to comply with all study procedures, and provide written informed consent.\n\n\\-\n\nExclusion Criteria:1)Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease and gastrointestinal malignancy).\n\n2)Patients who cannot commit to abstaining from any IBS-targeted medications (e.g., antidiarrheals, antispasmodics, rifaximin, 5-HT3 antagonists, opioid analgesics, or other agents affecting bowel habits or visceral pain perception) or centrally acting drugs (Antidepressants or anxiolytics) throughout the study period. Patients with long-term stable use (at least 3 months) of probiotics\u002Fsynbiotics who do not intend to change their regimen during the treatment period may be included.\n\n3)Prior major abdominal surgery (except appendectomy, cholecystectomy). 4)Severe cerebrocardiovascular diseases, impaired hepatic or renal function indicating organ failure, uncontrolled diabetes or hyperthyroidism, or uncontrolled psychiatric disorders.\n\n5)Implanted electrical devices (e.g., cardiac pacemaker, defibrillator) or other active implants that may be affected by electrical stimulation.\n\n6)Local skin disease or infection at the stimulation site, severe dermatologic sensitivity to electrodes or adhesives.\n\n7)Participants who are familiar with acupuncture acupoints and may therefore compromise study blinding will be excluded.\n\n8)Pregnancy or lactation. Women of childbearing potential who cannot confirm non-pregnancy will be required to undergo a urine or serum hCG test during screening, those with positive results will be excluded.\n\n9)Participation in another clinical trial within the past 3 months or currently enrolled in another interventional study.\n\n\\-",{"count":49,"type":21},200,[51],"NA","Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain and altered bowel habits. Under the Rome IV criteria, IBS can be classified into constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), mixed (IBS-M), and unclassified (IBS-U) subtypes. IBS-D represents one of the most clinically disruptive phenotypes due to the combined burden of abdominal pain and frequent loose stools1. These symptoms are the major drivers of impaired quality of life and healthcare utilization. Despite available pharmacologic treatments, recurrence rates remain high and adverse effects often limit patient satisfaction, creating an unmet need for safe and effective alternative therapies.\n\nTranscutaneous Electrical Acustimulation (TEA) is an emerging therapy which delivers appropriate electrical stimulation to acupoints that are in the vicinity of peripheral nerves through surface electrodes, has been demonstrated to improve bowel symptoms and visceral hypersensitivity by modulating autonomic function and brain-gut interaction2. Previous trials of TEA in IBS have shown improvement in bowel symptoms, pain, and quality of life, with good safety and tolerability2,3. However, multicenter evidence for IBS-D is lacking.\n\nThis trial aims to evaluate whether TEA can improve overall symptoms in patients with IBS-D. Specifically, the primary objective is to assess the effect of TEA on the composite responder rate, defined by concurrent improvement in both abdominal pain and loose stool days. Secondary objectives include evaluating broader symptom severity, stool characteristics, as well as on quality of life, psychological symptoms, and the durability of clinical benefits during follow-up.",[27],[55,56,57],"Transcutaneous Electrical Acustimulation","Irritable Bowel Syndrome","Multicenter Clinical Trial","2026-02-13",{"date":60,"type":32},"2026-02-20",{"date":62,"type":21},"2026-03-01",{"date":64,"type":21},"2028-02-28",{"name":66,"class":39},"First People's Hospital of Foshan",1]