A randomized clinical trial to compare to the efficacy of lansoprazole alone and lansoprazole+herb combination in erosive esophagitis patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001365

Enrollment

Registered

2015-01-28

Start date

2015-02-04

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Co-administration of permitted medicine) : 1. Oriental medicine co-administration group - Lansoprazole: 30 mg, once a day (OD), administered orally, before breakfast. - Banha-sasim-tang: 2 g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Adverse events and overall safty	—

Countries

Korea, Republic of

Contacts

Public Contactjintae jung

Daegu Catholic Univercity Medical Center

Outcome results