None listed
Conditions
Interventions
Drug : 1. Experimental group: Participants will receive modified Gwakjeongtang granules (10g) three times a day for a duration of 4 weeks.
2. Placebo group: Participants will receive placebo granules
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged between 19 and 65 years. 2. Participants who meet the criteria for irritable bowel syndrome according to the Rome IV criteria. 3. Participants with an average of worst abdominal pain over the past 10 days, rated on a scale of 0 to 10, equal to or greater than 3.0. 4. Participants who have experienced type 6 or type 7 stool according to the Bristol Stool Form Scale on at least one occasion for three or more days in the past 10 days, and the frequency of experiencing type 6 or type 7 stool is 25% or higher among the total number of bowel movements. 5. Participants who have undergone colonoscopy within the past 5 years with no clinically significant findings. 6. Participants with no clinically significant findings based on medical examinations and clinical laboratory tests. 7. Participants who have voluntarily provided written consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Participants with a medical history of organic colorectal diseases such as Crohn's disease, Celiac disease, Ulcerative colitis, or gastrointestinal malignancy. 2. Participants who have undergone major abdominal surgeries such as Gastrectomy or Cholecystectomy (excluding Appendectomy and Hemorrhoidectomy). 3. Participants with underlying conditions that could cause chronic diarrhea (e.g., hyperthyroidism, chronic pancreatitis, lactase deficiency, etc.). 4. Participants with a history of major psychiatric disorders within the past 2 years. 5. Participants with a history of acute infectious diseases within the past 2 weeks. 6. Participants with impaired liver or kidney function (screening criteria: AST, ALT, BUN, creatinine = 2 times the upper limit of normal). 7. Participants with uncontrolled hypertension, cardiovascular diseases, primary hyperaldosteronism, or electrolyte disorders (e.g., hypokalemia). 8. Participants who have taken the following medications within the past 4 weeks: • Systemic steroids • Antipsychotics • Antidepressants, anti-anxiety medications, Z-drugs • Narcotic analgesics (tramadol, etc.) 9. Participants who have taken the following medications within the past 2 weeks: •Antibiotics: rifaximin, neomycin, etc. •Gastrointestinal prokinetics •Serotonin receptor agonists and antagonists: tegaserod, alosetron, ramosetron, etc. •Non-steroidal anti-inflammatory drugs •Dietary fiber supplements, bulk-forming laxatives •Probiotics •Herbal medicine or preparations containing the same ingredients as the investigational product in the clinical trial 10. Participants who have received a vaccination within the past 4 weeks or have planned vaccinations during the study period. 11. Participants with medical conditions requiring hospitalization. 12. Participants who have taken investigational products in another clinical trial within the past 3 months. 13. Pregnant or lactating women. 14. Participants who do not use medically acceptable contraceptive methods during the clinical trial period. • Medically acceptable contraceptive methods include barrier methods, oral contraceptive pills, transdermal contraceptive patches, depot contraceptive injections, intrauterine devices, self or partner's sterilization (vasectomy, tubal ligation/laparoscopic occlusion, hysterectomy). 15. Participants for whom the investigators determine it difficult to conduct the clinical trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (overall responder is defined as a participant who has a daily response rate of more than 50% during the evaluation period. A daily responder is defined as a participant who experiences a minimum of 30% reduction in abdominal pain intensity compared to baseline and has Bristol Stool Form Scale type less than 5 for all bowel movements on that day or no bowel movements). | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate for abdominal pain intensity;Response rate for stool consistency;Global symptom assessment (abdominal pain, diarrhea, IBS symptoms);Average daily abdominal pain intensity and number of pain-free days;Average daily frequency of Bristol Stool Form Scale type 6 or 7 and number of days experiencing Bristol Stool Form Scale type 6 or 7;IBS Symptom severity scale (IBS-SSS);IBS quality of life (IBS-QOL);EQ-5D-5L (EuroQol-5 Dimension-5 Levels);WHOQOL-BREF (WHO QoL assessment instrument abbreviated version);(Exploratory outcome) Beck Depression Inventory (BDI-II);(Exploratory outcome) Beck Anxiety Inventory (BAI);(Exploratory outcome) Pain Catastrophizing Scale (PCS);(Exploratory outcome) Gastrointestinal Symptom Rating Scale (GSRS);(Exploratory outcome) Gut Quotient (GQ);(Exploratory outcome) Pattern identification questionnaire: Cold, Heat, Deficiency, and Excess pattern scores;(Exploratory outcome) Empathy Quotient (EQ);(Exploratory outcome) Autism-Spectrum Quotient (AQ);(Exploratory outcome) Obsessive-Compulsive Inventory-Revised (OCI-R);(Exploratory outcome) Social Network Questionnaire;(Exploratory outcome) Emotional rating and facial expression to emotional stimuli;(Exploratory outcome) Digital Infrared Thermal Imaging (abdominal region);(Exploratory outcome) Blood sample | — |
Countries
Korea, Republic of
Contacts
Public ContactNayeon Ha
Kyung Hee University Oriental Medical Center
Outcome results
None listed