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.
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;
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;
Parallel
Chang Ji'an capsule
DrugThe prescription consists of 13 medicinal ingredients including Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae (processed), and Radix Astragali.
Chang Ji'an capsule mimic
DrugMock capsules with "no pharmaceutically active ingredients", identical to the Chang Ji'an capsule in color, odor and appearance.
Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of Week 8 of treatment: patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
The abdominal pain response rate at the end of treatment weeks 2, 4, 6 and 8
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
The response rate of diarrhea (stool form) at the end of treatment weeks 2, 4 and 6
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to week endpoint: patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
Treatment response rate at the end of treatment weeks 2, 4, 6 and 8
Defined as the proportion of subjects who meet the following criteria during at least 50% of the treatment period from randomization to the week endpoint: 1.Intensity of abdominal pain, abdominal distension and abdominal discomfort: a decrease in the weekly average of worst abdominal pain, abdominal distension and abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline; 2.Stool form: 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Distention response rate at the end of treatment weeks 2, 4, 6 and 8
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal distention in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
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