Irritable Bowel Syndrome
Conditions
Interventions
Experimental Group:Elevating Yang, Relieving Depression, and Stopping Diarrhea Formula Granules
Control Group:Yang-Raising Depression-Relieving Diarrhea-Stopping Formula Formula Granules Simulant
Sponsors
Beijing University of Chinese Medicine Oriental Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with diarrhea-predominant irritable bowel syndrome of the liver qi stagnation and spleen deficiency type as per the above criteria; (2) During the run-in period (14±2 days prior to the start of treatment), weekly average pain scores =3 (on an 11-point Numerical Rating Scale, NRS-11); and at least one day per week with stool consistency classified as type 6 or 7 (according to the Bristol Stool Scale) for =2 days; (3) Irritable Bowel Syndrome Symptom Severity Scale scores =175; (4) Aged between 18 and 65 years; (5) Agree to undergo colonoscopy, which shows no abnormalities; (6) Provide written informed consent and are willing to receive the corresponding treatment.
Exclusion criteria
Exclusion criteria: (1) Diarrhea caused by confirmed infectious diarrhea, inflammatory bowel disease, parasitic infections, positive occult blood in stool, colorectal tumors, malabsorption syndrome, lactose intolerance (in combination with medical history), and systemic diseases. (2) Patients with concurrent diabetes, hyperthyroidism, or severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, hematopoietic systems, or other conditions that significantly impact survival (e.g., cancer). Abnormal liver and kidney function (AST, TBIL > 1.5 times the upper limit of normal reference values, Scr exceeding the upper limit of normal range), and clinically significant ECG abnormalities. (3) Patients with non-diarrheal irritable bowel syndrome or other organic digestive system diseases, or those with abdominal pain and discomfort caused by other organic lesions. (4) History of major surgery involving the stomach, liver, pancreas, or intestines (appendectomy, hemorrhoidectomy, or polypectomy are permitted if more than 3 months have passed), or history of cholecystectomy. (5) Patients currently using or requiring continued use of medications that may affect gastrointestinal function, including anticholinergics, 5-HT3 receptor antagonists, antidiarrheals, prokinetics, antidepressants, anxiolytics, and gut microbiota agents. (6) Pregnant or breastfeeding women, and those with plans for pregnancy in the near future. (7) Patients with a history of allergy to drugs used in the trial or severe food allergies. (8) Patients with suspected or confirmed history of alcohol or substance abuse. (9) Patients who have participated in other clinical trials within the past three months. (10) Patients who disagree with colonoscopy or have contraindications for colonoscopy. (11) Patients deemed by the investigator to have factors that make them unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-treatment overall efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall efficacy rate of patients during the follow-up period;Irritable Bowel Syndrome Symptom Severity Scale;Traditional Chinese Medicine Syndrome Scoring Evaluation;Quality of Life Evaluation;Psychological Assessment; | — |
Countries
China
Contacts
Public ContactPei Deng
Beijing University of Chinese Medicine Oriental Hospital
Outcome results
None listed