The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects

• Status: Completed
• Trial end date: 2018-11-08
• Target enrollment: 0
• Participant gender: All

Summary

This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Bundang Hospital

Criteria

Inclusion Criteria:

• Persons who was diagnosed with functional indigestion in adult over 19 years of age and did not require early medication was conducted with the participation

Exclusion Criteria:

• Persons who is allergic to natural substances and substances

• Persons who need treatment for reflux esophagitis, gastric ulcer, and acute gastritis according to gastroscopy findings

• Persons with past history of stomach or esophagus surgery, or patients who are unable to take esophagogastroduodenoscopy

• Persons who continue to apply medications that can cause ulcers such as steroids, nonsteroidal anti-inflammatory drugs and aspirin (Patients taking low-dose aspirin for prevention of cardiovascular disease were allowed)

• Persons diagnosed with malignant tumors within five years

• Persons who drink more than four times a week

• Severe liver failure (more than 2 .5 times the normal upper limit of ALT, AST, γGT)

• In case of a severe renal failure, including chronic or acute kidney failure

• Persons with uncontrolled diabetes, cerebrovascular disease,

• Persons diagnosed with diseases requiring surgery within three months

• Zollinger Ellison sy n drome, esophageal stenosis, duodenal ulcer, pancreatitis, absorption disorder, or malignant disease in the gastrointestinal tract

• Pregnant women, nursing mothers, having plans for pregnancy

• In case of participating another human study within four weeks