Irritable Bowel Syndrome with Diarrhea (Liver Qi Stagnation and Spleen Deficiency Syndrome)
Conditions
Interventions
Shuchang Decoction group:One pack per day: Radix Bupleuri 9g, Radix Saposhnikoviae 9g, processed Radix Codonopsis 12g, processed Atractylodes 12g, Poria 12g, Pericarpium Citri Reticulatae 9g, processe
Placebo group:One dose daily, composed of one-tenth the original formula's dosage and a bitter agent, divided into two oral administrations.
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Participants who meet the Rome IV diagnostic criteria for irritable bowel syndrome (IBS); (2) Individuals who have undergone colonoscopy within the past year with no abnormalities detected, or only hyperplastic polyps or tubular adenomas of the colon found; (3) Individuals aged between 18 and 70 years, with no gender restrictions; (4) Volunteers who agree to participate in this study and have signed the informed consent form, with the informed consent process conducted in accordance with GCP regulations.
Exclusion criteria
Exclusion criteria: (1) Individuals unable to complete the intestinal gas breath test; (2) Those with a history of inflammatory bowel disease, colorectal tumors, liver cirrhosis, parasitic infections, malabsorption syndrome, lactose intolerance, hyperthyroidism or hypothyroidism, chronic pancreatitis, etc.; (3) Patients with severe concurrent diseases of the circulatory, respiratory, digestive, hematopoietic, endocrine, nervous, urinary systems, or malignant tumors, as well as mentally ill patients; (4) Individuals with oral diseases (such as oral ulcers, oral malignancies, periodontitis, caries, dead teeth, exposed dental pulp, etc.) or those wearing dental orthodontic appliances; (5) Diarrhea or constipation caused by drug or food factors; (6) Individuals with a history of heavy alcohol consumption, suspected or confirmed abuse of alcohol or drugs; (7) Pregnant or breastfeeding women; (8) Individuals with cognitive impairments who cannot provide adequate informed consent; (9) Patients deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritable Bowel Syndrome Symptom Severity Scoring;Breath Analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine syndrome score;Abdominal pain/discomfort severity;Diarrhea Scoring;Irritable Bowel Syndrome Quality of Life Scale; | — |
Countries
China
Contacts
Public ContactLin Jiang
Shanghai University of Traditional Chinese Medicine Affiliated Longhua Hospital
Outcome results
None listed