KCT0008908尚未招募Unknown
Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: a randomized, double-blind, placebo-controlled, parallel, multicenter, investigator-initiated clinical trial
Kyung Hee University Oriental Medical Center0 个研究点目标入组 138 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
- 138
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. aged 19-65 years
- •2. Subjects who have have had a history of cough continuously for > 8 weeks
- •3. Subjects who have been diagnosed with reflux esophagitis within the last 1 year(including those who submitted documents diagnosed with reflux esophagitis at other hospitals or prescribing medicines for reflux esophagitis more than 4 weeks)
- •4. patients who consent to participate
排除标准
- •1. Present with abnormal findings, as established by chest x-ray
- •2. Present with abnormal findings on pulmonary function test (PFT)
- •3. Present with abnormal findings at nasal endoscopy that might lead to cough
- •4. Were diagnosed with acute respiratory diseases (including upper respiratory tract disorders) within the past month
- •5. Were diagnosed with chronic respiratory diseases(e.g., chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, and other chronic respiratory diseases) within the last 2 years
- •6. Were diagnosed with Los Angeles classification system grade C or higher GERD within the past year
- •7. Exhibit symptoms indicative of malignant disease within the GI tract (e.g., severe dysphagia, bleeding, weight loss, anemia, bloody stools)
- •8. History of surgical or endoscopic antireflux treatment
- •9. Currently have a disorder such as postnasal drip syndrome
- •10. Have active infection requiring systemic antibiotic therapy
- •11. Have a blood-clotting disorder
- •12. Have a lifetime smoking history of =20 packs (400 cigarettes)
- •13. Have used an angiotensin-converting enzyme inhibitor during the previous 4 months
- •14. Have used cough medicines, glucocorticoids, leukotriene receptor antagonists, anticholinergic drugs, long-acting ß2-agonists within the previous 2 weeks
- •15. Have used cough medicines as antihistamines within the previous 2 weeks
- •16. Have used medicines as PPIs, histamine receptor antagonists, mucosa-protective agents, GI motility promoters, antacids, antidepressants, anxiolytics, lower esophageal sphincter agonists within the previous 2 weeks
- •17. Have allergies or sensitivities to the experimental medicine/placebo
- •18. Have a body mass index < 18.5 kg/m2
- •19. Have an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level at least twofold higher than the upper limit of normal or a eGFR = 60 mL/min/1.73?
- •20. Hepatitis B (active) or hepatitis C, chronic liver disease
- •21. History of cerebrovascular accident(CVA)
- •22. Unregulated hypertension (high blood pressure of 160 mmHg in the condenser or high blood pressure exceeding 100 mmHg in the relaxation period of more than 3 minutes)
- •23. History of esophagostenosis, esophageal varix, Barrett’s esophagus, peptic ulcer or gastrointestinal bleeding, Zollinger-Ellison syndrome
- •24. Have used digitalis, mineralocorticoid, anticoagulants, high-dose aspirin(=325 mg is allowed) within previous 4 weeks
- •25. Have used potassium-containing drug treatment, licorice-containing drug treatment, glycyrrhizinic acid or its salts-containing drug treatment, loop diuretics (furosemide, ethacrynic acid) or thiazides diuretics (trichloromethiazide) within previous 4 weeks
- •26. Have a history of malignant tumors (e.g., lung or esophageal cancer) within the last 5 years
- •27. History of drug or alcohol abuse
- •28. Are pregnant or breastfeeding
- •29. Subjects who did not agree to use contraception by medically permitted methodsl
- •30. Have participated in clinical trials within the past 1 months
- •31. Are deemed unsuitable by the investigators
研究者
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