KCT0008523尚未招募Unknown
Efficacy and Safety of Gwakjeongtang-gami for Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Pilot Clinical Trial
Kyung Hee University Oriental Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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