Eupatilin protects surrogate markers of NSAIDs induced enteropathy in patients taking both NSAIDs and proton pump inhibitor: Prospective randomized double-blind controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006208

Enrollment

100

Registered

2021-05-28

Start date

2021-06-01

Completion date

Unknown

Last updated

2021-06-24

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

Conditions

None listed

Interventions

Drug : Patients who have taken both NSAID and PPI over 4 weeks were randomly assigned to either Eupatilin (Stillen 2X®, 90mg) with 1T twice for 8 weeks or placebo similar shape and color to study drug

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Outpatient aged 20-70 years ? On a course of NSAID for more than 4 weeks ? Patients with simultaneous administration of Proton Pump Inhibitor (PPI) for more than 4 weeks ? Patients with informed consent obtained before the initiation of any study-related processes

Exclusion criteria

Exclusion criteria: Patients were excluded if they ? had used following drugs as i. Other mucosal protective agents (such as sucralfate, misoprostol, rebamipide, eupatilin, Bismuth compounds, etc.) ii. Antibiotics including clarithromycin, amoxicillin, metronidazole, tetracycline, etc. iii. corticosteroids iv. H2RA (famotidine, nizatidine, lafutidine, etc) v. Complementary alternative medicine for GI function vi. Atazanavir, nelfinavir, rilpivirine vii. Other NSAIDS or PPI besides previous described NSAID/PPI during clinical trial period ? had previous gastric malignancy ? Had previous surgery for gastrointestinal organ or lower GI symptoms such as diarrhea/constipation ? had uncontrolled comorbidity with i. Dialysis ii. requirement with restrictive diet of potassium iii. Uncontrolled diseases relating to nephrology or hepatology iv. Inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis v. administration of anticoagulation or antiplatelet agents due to moderate or severe heart failure, congestive heart failure (NYHA II – IV), ischemic heart disease, peripheral artery disease or cerebrovascular disease ? had alarm signs (e.g., abnormal weight loss, hematochezia, anemia, or significant bowel habit changes) ? inappropriate conceptive method at least 14 days since completion of study period in women of childbearing age, pregnant or breastfeeding ? were drug users or alcoholics ? had hypersensitivity of study drug or other drugs ? had history of drug allergy (such as urticarial, fever, or itching, etc) ? inappropriate patients according to investigators’ judgement

Design outcomes

Primary

Measure	Time frame
direct measure in stool (Intestinal permeability & Intestinal inflammation) such as Calprotectin & Alpha-1-Antitrypsin (A1AT)	—

Secondary

Measure	Time frame
Indirect measure in urine and serum (Intestinal permeability) such as Zonulin, lactulose-mannitol test, nutrients (hemoglobin, protein, albumin, vitamin B12, magnesium, folic acid, calcium), and symptom questionnaire, Microbiome analysis?	—

Countries

Korea, Republic of

Contacts

Public ContactJin Young Yoon

Kyung Hee University Hospital at Gangdong

htherehthere@gmail.com+82-2-440-6095

Outcome results