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)
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;
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.;
Parallel
Changkang granules
Drug7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
Changkang Granules placebo
Drug7.5g/bag, 1 bag per dose, 2 doses per day, oral，4 consecutive weeks.
abdominal pain response rate
The primary efficacy endpoint is the weekly response rate to abdominal pain after 4 weeks of treatment.
The change in the average weekly score of abdominal pain compared to baseline
Starting from the import period, subject diary cards will be collected, and the subjects will rate the "most severe abdominal pain in the past 24 hours" daily. The non empty diary card information of the subjects in the random first 7 days of the import period will be used as the baseline. Calculate the average weekly abdominal pain compared to baseline.
Weekly Composite Response Rate
Calculate the proportion of subjects with composite responses over a 4-week period. The intensity of abdominal pain and stool characteristics were obtained from diary cards, with non empty diary card information from participants in the first 7 days of randomization as the baseline. Effective subjects are defined as those who simultaneously meet the following efficacy criteria for at least 50% of the observation period.
The change in total IBS-SSS score and each individual item score from baseline
Irritable bowel syndrome symptom severity scale(IBS-SSS)is a scale to assess the severity of illness in patients with irritable bowel syndrome.The scale has a total score of 500, with a minimum score of 0. Higher scores indicate more severe IBS-related symptoms.The IBS-SSS scale includes an evaluation of five dimensions: degree of abdominal pain, frequency of abdominal pain and bloating, satisfaction with bowel movements, and impact on quality of life (Appendix 2). The total IBS-SSS scores and changes in each dimension from baseline were compared between the two groups.
The change in total IBS-SSS score and each individual item score from baseline
Irritable bowel syndrome symptom severity scale(IBS-SSS)is a scale to assess the severity of illness in patients with irritable bowel syndrome.The scale has a total score of 500, with a minimum score of 0. Higher scores indicate more severe IBS-related symptoms.The IBS-SSS scale includes an evaluation of five dimensions: degree of abdominal pain, frequency of abdominal pain and bloating, satisfaction with bowel movements, and impact on quality of life (Appendix 2).Calculate the total IBS-SSS scores at 3 and 6 weeks after discontinuation, as well as the changes in scores for each dimension compared to baseline.
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