Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.

Patients report their IBS-related symptoms daily from run-in until end of treatment.

Inclusion criteria

• The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
• It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
• Male or female aged 18 to 65 years (including the boundary value);
• The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
• IBS-SSS score>175;
• Signed informed consent voluntarily.

Exclusion criteria

• Patients with IBS-C、IBS-M or IBS-U；
• Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
• Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
• Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
• Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
• With history of abdominal surgery (e.g., cholecystectomy);
• Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
• Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
• Taking emergency medication in the run-in period；
• Pregnant or lactating women；
• Those who are allergic to the test drug, emergency drug and its ingredients；
• Suspected or confirmed history of alcohol and drug abuse;
• Patients who participated in other clinical trials within one month before enrollment;
• The researchers believe that others are not suitable for clinical trials.