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

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Irritable Bowel Syndrome

Functional Dyspepsia

Treatments

Drug: BST-104 (Lonicera Flos Extract)

Drug: Placebo oral tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04008901

BST104-01

Details and patient eligibility

About

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

Full description

In this single center, double-blind, randomized clinical trial, patients diagnosed with FD using Rome III criteria were allocated to either test group (300 mg of BST-104, containing 175 mg of Flos Lonicera extracts, twice daily) or placebo group (300 mg placebo, twice daily). Male and female patients > 19 years of age who had mild to moderate FD were eligible. They had baseline endoscopic screening, and patients without active lesions (peptic ulcer disease or gastric erosions) were enrolled. Written informed consent was obtained from all participants.

Enrollment

92 patients

Sex

All

Ages

19 to 70 years old

Volunteers

Accepts Healthy Volunteers

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