Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With… (NCT07610434) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase III Clinical Trial of Changji'an Capsules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver-Qi Invading Spleen Syndrome)
China636 participantsStarted 2026-05-31
Plain-language summary
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.
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
. Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
. Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen;
. Aged ≥18 and ≤65 years, regardless of gender;
. 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 / 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;
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.
What they're measuring
1
Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment
Timeframe: Evaluation will be performed at Day 56.
Trial details
NCT IDNCT07610434
SponsorBeijing Hospital of Traditional Chinese Medicine
. 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;
. Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
. Individuals with fewer than 3 spontaneous bowel movements per week during the induction period;
. Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period;
. 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;
. Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening;
. 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;
. 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;
. Individuals with other mental disorders (excluding mild anxiety or depression);
. Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal);