KCT0003405已完成未知
A clinical study on safety and efficacy of Naesohwajung-tang on functional dyspepsia: Multi-center, randomized, double-blinded, placebo controlled trial
Kyung Hee University Oriental Medical Center0 个研究点目标入组 116 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Individuals between the ages of 19 and 75 years old and literate in Korean
- •2) Individuals who meet the Rome IV diagnostic criteria
- •3) Individuals who have an average dyspeptic symptom score of over 40 points (on a 0-100 point visual analog scale, VAS)
- •4) Individuals who receive no other treatment during the study
- •5) Individuals who voluntarily agree to participate in the study protocol and sign a written informed consent
排除标准
- •1) Individuals diagnosed with a gastrointestinal disease confirmed by esophagogastroduodenoscopy within the last year (diseases include reflux esophagitis, erosive esophagitis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma, esophageal cancer, gastric cancer, disease of biliary tract or pancreas, and Helicobacter pylori-related gastritis)
- •2) Individuals who have obvious signs of irritable bowel syndrome
- •3) Individuals who have alarm symptoms (weight loss, black or tar stool, or dysphagia)
- •4) Individuals who have serious structural defects (heart, lung, liver or kidney disease) or mental illness
- •5) Individuals who have a history of surgery associated with the gastrointestinal tract excluding an appendectomy more than six months prior
- •6) Individuals who are pregnant or breastfeeding
- •7) Individuals who are taking medication that may affect the gastrointestinal tract (a minimum wash-out period of two weeks is required before participating in the trial) (medications include, NSAIDs, aspirin, prokinetic drugs, histamine-2 receptor antagonists, proton pump inhibitors, antidepressants, antibiotics, anti-ulcer drugs, absorbents, antiflatulents, digestive drugs, antidiarrheics, laxatives, antiemetics, emetics, anticholinergics, gastrin receptor antagonists, prostaglandin analogues, mucosal protective agents, steroids, and anticoagulants)
- •8) Individuals who participated in another clinical trial less than 30 days before the start of the current trial
- •9) Individuals who are HIV-positive
- •10) Individuals who are currently using traditional Korean medicine as treatment, including herbal medicine or drugs that may affect the dyspepsia
- •11) Individuals who are incapable of attending the clinical trial (due to paralysis, serious mental illness, dementia, drug addiction, limited time available to attend hospital appointments, severe visual or hearing impairments, illiteracy etc.)
- •12) Individuals diagnosed with clotting disorders, leukopenia, or seizure disorders, having a pace-maker, receiving anticoagulant therapy, abnormal electrocardiography, and blood and urine test results at screening
- •i) Electrocardiography, Complete Blood Count (White Blood Cell, Hemoglobin, Hematocrit, Platelet), Liver Function Test (AST, ALT, rGT), Renal Function Test (BUN, Creatinine), ESR, Cholesterol (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, TG), Glucose, Routine Urine Analysis
- •ii) criteria of abnormality
- •- BUN, Creatinine >1.5 x upper limit of normal range
- •- AST, ALT >1.5 x upper limit of normal range
- •- Other results out of normal range with clinical dicision of principal investigator
- •13) Individuals who have uncontrolled chronic diseases despite appropriate managements (e.g., hypertension, diabetes mellitus)
- •14) Individuals who have been using of forbidden drugs less than 4 weeks before the start of the trial, excluding anti-hypertensive, hypoglycemic, and anti-hyperlipidemic treatment that might be considered not to affect the gastrointestinal tract and would be consistently used before or during the study
- •15) Individuals who show allergic response to NHT or placebo
- •16) Individuals who have symptoms and conditions that may affect the administration of the investigational drugs (e.g., dysphagia, clinically severe dyspepsia, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption)
- •17) Individuals who have a history of alcohol abuse or drug dependence
研究者
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