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出境医 / 临床实验 / The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
Study Description
Brief Summary:
This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Functional Dyspepsia Irritable Bowel Syndrome | Drug: BST-104 (Lonicera Flos Extract) Drug: Placebo oral tablet | Phase 3 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Random assignment, double blind placebo human application study |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 13, 2017 |
| Actual Primary Completion Date : | July 2, 2018 |
| Actual Study Completion Date : | November 8, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Treatment group
The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.
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Drug: BST-104 (Lonicera Flos Extract)
175 mg of Lonicera Flos extract in 1 tablet (300 mg)
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Placebo Comparator: Placebo group
The randomly assigned target was given a placebo for eight weeks.
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Drug: Placebo oral tablet
0 mg of Lonicera Flos extract in 1 tablet (300 mg)
|
Outcome Measures
Primary Outcome Measures :
- 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)
Secondary Outcome Measures :
- GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline [ Time Frame: 8 weeks ]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 [ Time Frame: 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 [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]
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
Eligibility Criteria
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital | |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707 | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 2, 2019 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | July 8, 2019 | ||||
| Actual Study Start Date ICMJE | February 13, 2017 | ||||
| Actual Primary Completion Date | July 2, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
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| Original Primary Outcome Measures ICMJE |
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration [ Time Frame: 8 weeks ] GSRS (Korean Gastrointestinal Symptom Rating Scale, from the Korean society of gastroenterology) total score improvement after 8 weeks of administration, compared to Baseline Each item is rated on a 7-point Likert scale : stomach pain, heartburn, acid reflux, hunger pains, nausea, rumbling, bloating, burping, flatus, constipation, diarrhea, loose stools, hard stools, urgency (need to have a bowel movement), sensation of not completely emptying the bowels
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects | ||||
| Official Title ICMJE | 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 | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Random assignment, double blind placebo human application study Primary Purpose: Treatment
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Choi Y, Kim N, Noh GT, Lee JY, Lee DH. The Efficacy and Safety of GCWB104 (<i>Flos</i> 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
92 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | November 8, 2018 | ||||
| Actual Primary Completion Date | July 2, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04008901 | ||||
| Other Study ID Numbers ICMJE | BST104-01 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Nayoung Kim, Seoul National University Bundang Hospital | ||||
| Study Sponsor ICMJE | Seoul National University Bundang Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Seoul National University Bundang Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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