The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects
- Conditions
- Functional DyspepsiaIrritable Bowel Syndrome
- Interventions
- Drug: Placebo oral tabletDrug: BST-104 (Lonicera Flos Extract)
- Registration Number
- NCT04008901
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Placebo oral tablet The randomly assigned target was given a placebo for eight weeks. Treatment group BST-104 (Lonicera Flos Extract) The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.
- Primary Outcome Measures
Name Time Method GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration 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
Name Time Method Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks 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 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
GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline 8 weeks Total GSRS score improvement rate after 8 weeks of administration, compared to Baseline
Changes in dyepepsia-related quality of life 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
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of