A randomized clinical trial to compare to the efficacy of lansoprazole alone and lansoprazole+herb combination in erosive esophagitis patients.
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001365
- Lead Sponsor
- Comprehensive and Integrative Medical Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
1. Inclusion criteria (Must fulfill all conditions)
? Patients with GERD, with esophageal mucosal break(s), as shown by upper gastrointestinal endoscopy and belonging to A, B, C, or D group as per Los Angeles classification; who also have one or more weekly episodes of symptoms such as chest burn, gastric acid reflux, and/or heartburn (including chest pain).
? Patients who are 20 to 85 years old
? Patients with no cognitive impairment
? Patients who voluntarily agree to participate and sign the consent form themselves or the form is signed by their guardian
? Patients for whom follow-up observations are possible throughout the study period
2. Exclusion criteria (Any one of the conditions is fulfilled)
? Have taken H2-receptor antagonist, prostaglandin agents, antimicrobials, PPI agents, beta-blocking agents, and/or calcium-blocking agents for a minimum of 5 consecutive days within 2 weeks prior to the start of the study; or have taken non-steroid anti-inflammatory agents, aspirin, high-dose steroids, and/or anticoagulants
? History of gastrectomy
? Show gastrointestinal bleeding or other abnormal bleeding in upper gastrointestinal endoscopy
? History of hematologic diseases that are contraindicated, in a stomach biopsy
? Pregnant or breastfeeding
? History of alcohol consumption or drug abuse
? Show =3 cm Barrett’s esophagus lesions or noticeable dysplastic changes in the esophagus in upper gastrointestinal endoscopy
? History of any of the following within 3 months prior to the start of the study (Zollinger-Ellison syndrome, esophageal stenosis, gastrointestinal malignant diseases, liver enzyme level = 2 times the normal level, severe liver disease, chronic renal disease, renal diseases, including renal function impairment, cerebrovascular disease, and patients who may need surgery during study duration)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method gastroesophageal reflux disease cure rate ;The Patient Assessment of Upper Gastrointestinal Disorders Quality of Life(PAGI-QoL), Patient Assessment of upper Gastrointestinal symptom severity Index (PAGI-SYM) survey
- Secondary Outcome Measures
Name Time Method Adverse events and overall safty