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Completed

NCT Number: NCT04008901

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

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

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Key information

Conditions

Functional Dyspepsia Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BST-104 (Lonicera Flos Extract)

Drug

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

Placebo oral tablet

Drug

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

Primary outcomes

  1. GSRS total score improvement : GSRS score at baseline - GSRS score after 8 weeks of administration

    Time frame: 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 outcomes

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

    Time frame: 8 weeks

    Total GSRS score improvement rate after 8 weeks of administration, compared to Baseline

  2. Improvement of 15 individual symptom scores of GSRS : symptom score at baseline - symptom score after 8 weeks

    Time frame: 8 weeks

    15 individual symptoms of upper and lower abdominal discomfort after 8 weeks of administration, compared to Baseline

  3. Changes in serum antioxidant and anti-inflammatory marker level

    Time frame: 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

  4. Changes in dyepepsia-related quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 5, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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