The Efficacy and Safety of "BST104" (Lonicera Flos Extract) in Mild to Moderate Functional Dyspepsia Subjects

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008901
• Other study ID #: BST104-01
• Status: Completed
• Phase: Phase 3
• Start date: February 13, 2017
• Est. completion date: November 8, 2018

Study information

• Verified date: April 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to prove the efficacy of BST-104 in patients with mild to moderate FD.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 8, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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, ?GT)

• 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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Irritable Bowel Syndrome

Intervention

Drug:
• BST-104 (Lonicera Flos Extract)
175 mg of Lonicera Flos extract in 1 tablet (300 mg)
• Placebo oral tablet
0 mg of Lonicera Flos extract in 1 tablet (300 mg)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	8 weeks
Secondary	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	8 weeks
Secondary	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	8 weeks
Secondary	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	8 weeks
Secondary	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	8 weeks