Functional DyspepsiaPhase 3NCT04008901
The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
A Phase 3 study testing BST-104 (Lonicera Flos Extract) in people with Functional Dyspepsia and Irritable Bowel Syndrome, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Irritable Bowel Syndrome
- What is being tested?
- BST-104 (Lonicera Flos Extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Feb 2017to 8 Nov 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
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
This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.
Read the 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
- Being tested
- BST-104 (Lonicera Flos Extract), Placebo oral tablet
- Keywords
- Functional dyspepsia, Irritable Bowel Syndrome, Lonicera Flos, GSRS, Antioxidant
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BST-104 (Lonicera Flos Extract)Drug
175 mg of Lonicera Flos extract in 1 tablet (300 mg)
Placebo oral tabletDrug
0 mg of Lonicera Flos extract in 1 tablet (300 mg)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks. Receives: Drug: BST-104 (Lonicera Flos Extract) |
| Placebo group | Placebo comparator | The randomly assigned target was given a placebo for eight weeks. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start13 Feb 2017
- Primary completion2 Jul 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008901
- Sponsor's protocol ID
- BST104-01
- Status last verified
- Apr 2023
- First submitted
- 2 Jun 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31945816
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04008901
- Acronym / sponsor ID
- BST104-01
- Conditions
- Functional Dyspepsia, Irritable Bowel Syndrome
- Keywords
- Functional dyspepsia, Irritable Bowel Syndrome, Lonicera Flos, GSRS, Antioxidant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Drug: BST-104 (Lonicera Flos Extract)The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks. |
| Placebo group | Placebo comparator | Drug: Placebo oral tabletThe randomly assigned target was given a placebo for eight weeks. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BST-104 (Lonicera Flos Extract)175 mg of Lonicera Flos extract in 1 tablet (300 mg) | Drug | Treatment group |
| Placebo oral tablet0 mg of Lonicera Flos extract in 1 tablet (300 mg) | Drug | Placebo group |
Primary outcome
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration
Time frame: 8 weeks
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)
4 secondary outcomes
GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline
Time frame: 8 weeks
Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks
Time frame: 8 weeks
Changes in serum antioxidant and anti-inflammatory marker level
Time frame: 8 weeks
Changes in dyepepsia-related quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 31945816Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BST-104 (Lonicera Flos Extract) in people with Functional Dyspepsia and Irritable Bowel Syndrome, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.