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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2018-11-08

Brief Summary

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

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Detailed Description

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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

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Functional Dyspepsia Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a single center, random assignment, double blind placebo human application study. If a subject agrees in writing to participate in the human aptitude test, the medical examination required in accordance with the human aptitude test plan were conducted and randomly assigned only to those who are suitable for the selection criteria. The randomly assigned target was given a Lonicera Flos extract (BST104) 250 mg/day or placebo for eight weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Random assignment, double blind placebo human application study

Study Groups

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Treatment group

The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.

Group Type ACTIVE_COMPARATOR

BST-104 (Lonicera Flos Extract)

Intervention Type DRUG

175 mg of Lonicera Flos extract in 1 tablet (300 mg)

Placebo group

The randomly assigned target was given a placebo for eight weeks.

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

0 mg of Lonicera Flos extract in 1 tablet (300 mg)

Interventions

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BST-104 (Lonicera Flos Extract)

175 mg of Lonicera Flos extract in 1 tablet (300 mg)

Intervention Type DRUG

Placebo oral tablet

0 mg of Lonicera Flos extract in 1 tablet (300 mg)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes