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

NCT04008901 | Completed Phase 3

• 1 other identifier: BST104-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Dyspepsia; Irritable Bowel Syndrome

Keywords

Functional dyspepsia; Irritable Bowel Syndrome; Lonicera Flos; GSRS; Antioxidant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• GSRS improvement rate : (total GSRS score at baseline - total GSRS score after 8 weeks of administration) / GSRS score at baseline

  8 weeks

• 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

• Changes in dyepepsia-related quality of life

  8 weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

The randomly assigned target was given a Lonicera Flos extract (BST104) 175 mg/day for eight weeks.

Drug: BST-104 (Lonicera Flos Extract)

Placebo group

PLACEBO COMPARATOR

The randomly assigned target was given a placebo for eight weeks.

Drug: Placebo oral tablet

Interventions

BST-104 (Lonicera Flos Extract) DRUG

175 mg of Lonicera Flos extract in 1 tablet (300 mg)

Treatment group

Placebo oral tablet DRUG

0 mg of Lonicera Flos extract in 1 tablet (300 mg)

Placebo group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31945816 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Random assignment, double blind placebo human application study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: July 5, 2019
• Study Start: February 13, 2017
• Primary Completion: July 2, 2018
• Study Completion: November 8, 2018
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

KR (1)