Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predo… (NCT06753890) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of Changkang Granules in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea (Liver qi Affecting the Spleen Pattern)
China520 participantsStarted 2024-12-30
Plain-language summary
This study will evaluate the efficacy and safety of Changkang granules in the treatment of irritable bowel syndrome with predominant Diarrhea ( Liver qi affecting the spleen pattern)
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
. Age 18-65 years (inclusive), regardless of gender;
. Meet the Western medical diagnostic criteria for Irritable Bowel Syndrome with Predominant Diarrhea (Rome IV);
. Meet the Traditional Chinese Medicine diagnostic criteria for Liver qi affecting the spleen pattern
. Have a weekly average NRS score for abdominal pain ≥3.0 during the Run-In Period period, and have at least 2 days per week with stool form of type 6 or 7 (Bristol Stool Scale) during the Run-in period;
. Have an IBS-SSS score \>175 at baseline;
. Have completed a colonoscopy within the past 12 months prior to the Run-in period, and meet one of the following conditions: ① Normal colonoscopy results with no organic changes; ② Abnormal colonoscopy report, such as hemorrhoids, polyps (diameter ≤5mm and number ≤3), etc., which the investigator determines can be included; ③ Previous colonoscopy report indicating polyps \>5mm in diameter or \>3 in number, which after endoscopic treatment 6 months ago, residual polyps are ≤5mm in diameter and ≤3 in number, and the investigator determines can be included;
. Voluntarily sign the informed consent form, and from the time of signing the informed consent form until the end of the last visit of the trial, the participant voluntarily accepts health education and maintains their usual diet and lifestyle, such as not changing dietary structure or exercise patterns.
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.
. Subjects who have less than 3 spontaneous bowel movements per week during the run-in period; or at least 2 days per week during the run-in period with stool consistency classified as type 1 or 2 on the Bristol Stool Scale;
. Patients with a history of severe mental or psychological disorders, or those scoring ≥63 on the Self-Rating Depression Scale (SDS), or ≥60 on the Self-Rating Anxiety Scale (SAS) during the screening period;
. Patients with a confirmed history of organic gastrointestinal diseases, including both gastrointestinal and non-gastrointestinal digestive system diseases, such as chronic superficial gastritis with erosions or bleeding of grade II or higher, chronic atrophic gastritis, peptic ulcers, inflammatory bowel disease, intestinal tuberculosis, intestinal ulcers, intestinal obstruction, intestinal adhesions, eosinophilic gastroenteritis, cholelithiasis with recurrent cholecystitis (patients with gallstones or gallbladder polyps ≤0.5 cm in diameter and no significant symptoms may be exempted from exclusion upon investigator's judgment), tuberculous peritonitis, liver cirrhosis, and digestive system tumors, etc.;
. Patients diagnosed with other diseases that affect the evaluation of abdominal pain and diarrhea, such as diarrhea caused by lactose intolerance, diarrhea after cholecystectomy, abdominal pain due to endometriosis, abdominal pain caused by hepatic and biliary stones or cholecystitis, abdominal pain due to chronic pancreatitis, etc.;
. Patients with a history of systemic diseases affecting gastrointestinal function, such as diabetes mellitus, hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases (such as allergic colitis, allergic purpura, Behcet's syndrome, systemic lupus erythematosus), etc.;
. Patients with a history of major abdominal surgery involving the gastrointestinal tract, liver, gallbladder, spleen, or pancreas (subjects who have undergone appendectomy or cesarean section without impact on gut function may be exempted from exclusion upon investigator's judgment);
. Patients with unexplained recurrent positive fecal occult blood, unintentional weight loss, anemia, fever, or jaundice prior to screening;
. Abnormal liver function at baseline (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function at baseline (Cr \>upper limit of normal);