Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) (NCT07721012) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
China120 participantsStarted 2026-07-31
Plain-language summary
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase II clinical trial. Its purpose is to evaluate the efficacy and safety of Huanghou Zhixie Diwan in subjects with irritable bowel syndrome with diarrhea (Large Intestinal Damp-heat syndrome) after 4 weeks of treatment.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged from 18 to 65 years old, regardless of gender.
. Meeting the Western medicine diagnostic criteria for IBS-D (Rome IV criteria).
. Conforming to the TCM syndrome differentiation criteria for Large Intestinal Damp-heat.
. During the run-in period, the weekly average score of abdominal pain is ≥ 3 points based on the 11-point (0-10) Numerical Rating Scale (NRS); and there are at least 2 days per week with stool consistency classified as Type 6 or Type 7 according to the Bristol Stool Scale.
. The total score of the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) at baseline is ≥ 175 points.
. Colonoscopy performed within 12 months prior to the run-in period, and meeting one of the following conditions for enrollment:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients diagnosed with irritable bowel syndrome classified as IBS-C, IBS-M or IBS-U.
. Patients with a confirmed diagnosis of digestive system diseases in medical history or at screening, including peptic ulcer (excluding those with healed ulcers assessed by the investigator to have no impact on efficacy and safety evaluation), inflammatory bowel disease, intestinal tuberculosis, intestinal obstruction, intestinal adhesion, eosinophilic gastroenteritis, tuberculous peritonitis, liver cirrhosis, etc.
. Patients with acute diarrhea and/or severe abdominal pain caused by other diseases within 1 month prior to screening, or those suffering from other diseases assessed by the investigator to interfere with efficacy evaluation and increase safety risks.
. Patients with a history of abdominal surgery who may present symptoms similar to IBS as judged by the investigator (appendectomy and cesarean section are excluded).
. Patients with a confirmed diagnosis of systemic diseases affecting gastrointestinal function in medical history or at screening, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (e.g. allergic enteritis, Henoch-Schönlein purpura, Behçet's syndrome, systemic lupus erythematosus), etc.
. Patients complicated with other painful conditions such as arthritis and migraine that may interfere with Numeric Rating Scale (NRS) pain assessment; female patients with severe dysmenorrhea requiring analgesic medication.
. Patients with malignant tumors within the past 5 years or diagnosed at screening.
. Participants presenting gastrointestinal alarm symptoms within 14 days prior to screening, including hematochezia, positive fecal occult blood test, anemia, ascites, nocturnal diarrhea, unexplained weight loss or fever, etc., who are deemed ineligible for enrollment by the investigator.