Efficacy and Safety of Gwakjeongtang-gami for Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Pilot Clinical Trial

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0008523
• Lead Sponsor: Kyung Hee University Oriental Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified