diarrhea-type irritable bowel syndrome(Liver Qi Overacting on the Spleen Syndrome)
Conditions
Interventions
Experimental drug group:Intestine Calm Capsule Mimetic, 4 capsules per dose, 3 times a day, orally
Placebo group:Intestine Calm Capsule Mimetic, 4 capsules per dose, 3 times a day, orally
Sponsors
Beijing Traditional Chinese Medicine Hospital, Affiliated with Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medicine diagnostic criteria for diarrhea-predominant irritable bowel syndrome; (2) Meet the Traditional Chinese Medicine syndrome differentiation criteria for liver Qi invading the spleen; (3) Aged =18 and =65 years, regardless of gender; (4) 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; (5) Self-Rating Anxiety Scale (SAS) 5mm or number >3, but after endoscopic treatment within 6 months prior to screening, remaining polyps are =5mm in diameter and =3 in number, deemed eligible by the investigator; (7) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals with fewer than 3 spontaneous bowel movements per week during the induction period; (2) Individuals with stool consistency of type 1 or 2 (Bristol Stool Form Scale) on at least 2 days per week during the induction period; (3) 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; (4) Individuals who have used other medications for irritable bowel syndrome within 1 week prior to screening; (5) Individuals with non-IBS-D or other organic gastrointestinal lesions (excluding superficial gastritis, grade I erosive gastritis, or chronic atrophic gastritis found on endoscopy but deemed by the investigator to be eligible for inclusion (e.g., no mucosal erosion or bleeding observed endoscopically, and the patient has no upper abdominal fullness, upper abdominal pain, or acid reflux)), or other organic lesions that the investigator judges may cause abdominal pain, bloating, or discomfort; (6) Individuals with diabetes, hyperthyroidism, or serious primary diseases of the cardiovascular, cerebrovascular, liver, kidney, hematopoietic systems, or other serious diseases affecting survival (e.g., tumors), abnormal liver and kidney function (AST, ALT > 1.5 times the upper limit of normal reference range, Scr above the upper limit of normal reference range), and clinically significant ECG abnormalities; (7) Individuals with other mental disorders (excluding mild anxiety or depression); (8) Individuals with a history of gastrointestinal surgery (excluding appendectomy or intestinal polyp removal); (9) Individuals who, within 2 weeks prior to screening, are using or need to continue using medications that may affect gastrointestinal function (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal drugs, antacids, prokinetic drugs, antidepressants (fluoxetine for at least 28 days), anti-anxiety drugs, intestinal microbiota regulators, traditional Chinese medicine decoctions, etc.); (10) Individuals allergic to 3 or more medications or foods, or known allergies to Xiangjie Capsules and its components, as well as emergency medication Pivabromium tablets; (11) Individuals who took emergency medication (Pivabromium tablets) during the last week of the induction period; (12) Individuals who took prohibited medications during the induction period; (13) Individuals suspected of or confirmed with a history of alcohol or drug abuse; (14) Pregnant women, breastfeeding women, or women of childbearing age planning to conceive; or female participants of childbearing potential and male participants (whose partners are women of childbearing potential) who do not agree to voluntarily use effective contraception from screening to 3 months after the last dose; (15) Individuals with cognitive impairment unable to provide fully informed consent; (16) Individuals positive for hepatitis B surface antigen, HIV antibody, hepatitis C antibody, or syphilis treponemal antibody; (17) Individuals who have participated in another clinical trial within the past month; (18) Individuals known to have familial colorectal cancer syndrome; (19) Individuals who, in the opinion of the investigator, have other factors making them unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment at the end of week 2, week 4, week 6, and week 8, abdominal pain response rate;Treatment at the end of 2 weeks, 4 weeks, and 6 weeks, diarrhea (stool characteristics) response rate;Treatment at the end of 2 weeks, 4 weeks, 6 weeks, and 8 weeks, treatment response rate;Treatment at the end of 2 weeks, 4 weeks, 6 weeks, and 8 weeks, bloating response rate;Response rate of abdominal discomfort at the end of 2, 4, 6, and 8 weeks of treatment;Changes in the number of days with diarrhea in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment;Changes in the average number of diarrhea episodes in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment;Changes in bowel urgency scores compared to baseline at the end of weeks 2, 4, 6, and 8, and in the past 2 weeks;Changes from baseline in IBS Symptom Severity Score (IBS-SSS) and Quality of Life scale score (IBS-QOL) at the end of 2, 4, 6, and 8 weeks of treatment;At the end of weeks 2, 4, 6, and 8 of treatment, the change in Traditional Chinese Medicine syndrome scores from baseline;At the end of the 4-week and 8-week follow-up periods, the proportion of subjects whose diarrhea continued to ease and did not worsen;At the end of the 4-week and 8-week follow-up periods, the proportion of subjects with diarrhea related to diarrhea-predominant irritable bowel syndrome;Dosage of emergency drugs; | — |
Countries
China
Contacts
Public ContactZhang Shengsheng
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed