NCT04008901

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

A Single-center, Randomized, Double-blind, Placebo-controlled, Intervention Study for the Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Functional Dyspepsia
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	BST-104 (Lonicera Flos Extract)	175 mg of Lonicera Flos extract in 1 tablet (300 mg)
DRUG	Placebo oral tablet	0 mg of Lonicera Flos extract in 1 tablet (300 mg)

Timeline

• Start date: 2017-02-13
• Primary completion: 2018-07-02
• Completion: 2018-11-08
• First posted: 2019-07-05
• Last updated: 2023-04-18

Locations

1 site across 1 country: South Korea