Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0008908
• 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: 13 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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