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 range18 Years – 65 Years
SexALL
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: ①Normal 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
✕. 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);