Clinical trial NCT04008901: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Dyspepsia
Irritable Bowel Syndrome
Keywords: Functional dyspepsia
Irritable Bowel Syndrome
Lonicera Flos
GSRS
Antioxidant
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration
timeFrame: 8 weeks
Secondary outcomes:
measure: GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline
timeFrame: 8 weeks
measure: Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks
timeFrame: 8 weeks
measure: Changes in serum antioxidant and anti-inflammatory marker level
timeFrame: 8 weeks
measure: Changes in dyepepsia-related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
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.