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

Primary Purpose

Functional Dyspepsia, Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BST-104 (Lonicera Flos Extract)
Placebo oral tablet
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional dyspepsia, Irritable Bowel Syndrome, Lonicera Flos, GSRS, Antioxidant

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 2, 2019
Last Updated
April 16, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04008901
Brief Title
The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
November 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Irritable Bowel Syndrome
Keywords
Functional dyspepsia, Irritable Bowel Syndrome, Lonicera Flos, GSRS, Antioxidant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Random assignment, double blind placebo human application study
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The randomly assigned target was given a placebo for eight weeks.
Intervention Type
Drug
Intervention Name(s)
BST-104 (Lonicera Flos Extract)
Intervention Description
175 mg of Lonicera Flos extract in 1 tablet (300 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
0 mg of Lonicera Flos extract in 1 tablet (300 mg)
Primary Outcome Measure Information:
Title
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline
Description
Total GSRS score improvement rate after 8 weeks of administration, compared to Baseline
Time Frame
8 weeks
Title
Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks
Description
15 individual symptoms of upper and lower abdominal discomfort after 8 weeks of administration, compared to Baseline
Time Frame
8 weeks
Title
Changes in serum antioxidant and anti-inflammatory marker level
Description
Changes in serum antioxidant (8-OHdG, Thiobarbituric acid reactive substances (TBARS), total antioxidant, hs-CRP level) after 8 weeks of administration, compared to baseline
Time Frame
8 weeks
Title
Changes in dyepepsia-related quality of life
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31945816
Citation
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.
Results Reference
derived

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

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