Pattern Identification and Herbal Prescrip-tion of Irritable Bowel Syndrome in a Korean Medicine Hospital

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patient group
1. Males and females aged 19 to under 65
2. Participants with irritable bowel syndrome according to Rome IV diagnostic criteria
3. Participants whose weekly average of the most severe abdominal pain over the past seven days was 3.0 or higher on a scale of 0 to 10
4. Participants who have experienced stool type 6 or 7 according to the Bristol Stool Form Scale in the last seven days for at least two days.
5. Participants who have confirmed that there are no clinically meaningful findings through colonoscopy performed within five years
6. Participants who do not have clinically meaningful findings in physical examinations and clinical laboratory examinations
7. Participants who voluntarily agreed to participate in the study

Healthy control group
1. Males and females aged 19 to under 65
2. Participants who do not have other functional/organic disorders, including gastrointestinal disorders, through an interview and physical examination
3. Participants who have not experienced abdominal pain in the last seven days
4. Participants who have not experienced stool type 6 or 7 according to the Bristol Stool Form Scale in the last seven days.
5. Participants who do not have clinically meaningful findings in the physical examination and clinical laboratory examination
6. Participants who voluntarily agreed to participate in the study

Exclusion Criteria

Patient group
1. Participants with a history of organic bowel diseases such as Crohn's disease, Celiac disease, Ulcerative colitis, and gastrointestinal malignancy
2. Participants who have undergone major abdominal surgery such as gastrectomy or cholecystectomy (cf. Appendectomy and Hemorrhoidectomy are not major abdominal surgery)
3. Participants with a history of major psychiatric diseases within two years
4. Participants who have taken the following drugs within four weeks
- Systemic steroids
- Antipsychotics
- Antidepressants, anxiolytics, Z-drugs
5. Participants who have taken the following drugs within two weeks
- Antibiotics
- Prokinetics
- Antispasmodics: anticholinergic/muscarinic drugs, smooth muscle relaxants, calcium channel blockers
- Antidiarrhoticas: loperamide, etc.
- Serotonin receptor agonists and antagonists: tegaserod, alosetron, etc.
- Non-steroidal anti-inflammatory drugs
- Bulk-forming laxatives (Dietary fiber preparations, etc), Osmotic laxatives
- Probiotics

Healthy control group
1. Participants with a history of functional gastrointestinal disorders such as Irritable bowel syndrome, Functional constipation, Functional diarrhea, Functional abdominal discomfort
2. Participants with a history of organic bowel diseases such as Crohn's disease, Celiac disease, Ulcerative colitis, and gastrointestinal malignancy
3. Participants who have undergone major abdominal surgery such as gastrectomy or cholecystectomy (cf. Appendectomy and Hemorrhoidectomy are not major abdominal surgery)
4. Participants with a history of major psychiatric diseases within two years
5. Participants who have taken the following drugs within four weeks
-Systemic steroids
-Antipsychotics
-Antidepressants, anxiolytics, Z-drugs
6. Participants who have taken the following drugs within two weeks
-Antibiotics
-Prokinetics
-Antispasmodics: anticholinergic/muscarinic drugs, smooth muscle relaxants, calcium channel blockers
-Antidiarrhoticas: loperamide, etc.
-Serotonin receptor agonists and antagonists: tegaserod, alosetron, etc.
-Non-steroidal anti-inflammatory drugs
-Bulk-forming laxatives (Dietary fiber preparations, etc), Osmotic laxatives
-Probiotics

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pattern identification 1: Presence of Cold, Heat, Deficiency, and Excess pattern;Pattern identification 2: Presence of Liver qi stagnation, Spleen qi deficiency, Spleen and stomach dampness-heat, and Kidney yang deficiency pattern;Herbal medicine prescription plan

Secondary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS);IBS Symptom severity scale (IBS-SSS);IBS quality of life (IBS-QOL);Bristol Stool Form Scale (BSFS) in the last three days;Gastrointestinal Symptom Rating Scale (GSRS);Gut Quotient (GQ);Beck Depression Inventory (BDI-II);Beck Anxiety Inventory (BAI);Empathy Quotient (EQ);Interpersonal Reactivity Index (IRI);Social Network Questionnaire;Emotional Stimulus Test;Pattern identification questionnaire: Cold, Heat, Deficiency, and Excess pattern scores;Tongue image: Color of tongue body and coating, and tongue coating percentage