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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration
研究概览
简要总结
This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Random assignment, double blind placebo human application study
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment group
The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.
干预措施: BST-104 (Lonicera Flos Extract) (Drug)
Placebo group
The randomly assigned target was given a placebo for eight weeks.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration
时间窗: 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)
次要结局
- Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks(8 weeks)
- Changes in serum antioxidant and anti-inflammatory marker level(8 weeks)
- GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline(8 weeks)
- Changes in dyepepsia-related quality of life(8 weeks)
研究者
Nayoung Kim
Professor
Seoul National University Bundang Hospital