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

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

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Irritable Bowel Syndrome
• Intervention / Treatment: Drug: BST-104 (Lonicera Flos Extract); Drug: Placebo oral tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group; The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.	Drug: BST-104 (Lonicera Flos Extract); 175 mg of Lonicera Flos extract in 1 tablet (300 mg)
Placebo Comparator: Placebo group; The randomly assigned target was given a placebo for eight weeks.	Drug: Placebo oral tablet; 0 mg of Lonicera Flos extract in 1 tablet (300 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration	GSRS (Gastrointestinal Symptom Rating Scale) total score improvement after 8 weeks of administration, compared to Baseline GSRS is consisted of 15 upper and lower gastrointestinal symptoms, and each item is rated on a 7-point Likert scale, 0 = no symptoms, 7 = worst Total score scale : 0~105 (15x7), 0 = no symptoms, 105 = worst, decreased score is considered as improvement, increased score is considered as worsening stomach pain (0~7) heartburn (0~7) acid reflux (0~7) hunger pain (0~7) nausea (0~7) rumbling (0~7) bloating (0~7) burping (0~7) flatus (0~7) constipation (0~7) diarrhea (0~7) loose stools (0~7) hard stools (0~7) urgency (need to have a bowel movement) (0~7) sensation of not completely emptying the bowels (0~7) total score (sum of 15 symptoms scores, 0~105)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline	Total GSRS score improvement rate after 8 weeks of administration, compared to Baseline	8 weeks
Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks	15 individual symptoms of upper and lower abdominal discomfort after 8 weeks of administration, compared to Baseline	8 weeks
Changes in serum antioxidant and anti-inflammatory marker level	Changes in serum antioxidant (8-OHdG, Thiobarbituric acid reactive substances (TBARS), total antioxidant, hs-CRP level) after 8 weeks of administration, compared to baseline	8 weeks
Changes in dyepepsia-related quality of life	Changes in dyepepsia-related quality of life using NDI (Nepean Dyspepsia Index) questionnaire after 8 weeks of administration, compared to baseline NDI-K (Nepean Dyspepsia Index Korean) is consisted of 5 categories and 25 questions of gastrointestinal symptoms, with each question is rated on a 5-point Likert scale, 0 = worst, 5 = no symptoms Total score scale : (sum of individual question score) x 100/125 0~100, 0 = worst condition, 100 = no symptoms, decreased score is considered as worsening, increased score is considered as improvement Interference daily activities/work (0~30) Knowledge/control (0~20) Eating/drinking (0~15) Sleep disturbance (0~45) Work/study (0~15) Total score (sum of individual question score) x 100/125	8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Choi Y, Kim N, Noh GT, Lee JY, Lee DH. The Efficacy and Safety of GCWB104 (Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study. Gut Liver. 2020 Jan 15;14(1):67-78. doi: 10.5009/gnl19283.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): July 2, 2018
• Study Completion (Actual): November 8, 2018

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Antioxidant; Functional dyspepsia; GSRS; Lonicera Flos
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Dyspepsia; Irritable Bowel Syndrome
• Other Study ID Numbers: BST104-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No