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Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis

Primary Purpose

Erosive Gastritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hizikia Fusiformis extract
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Erosive Gastritis focused on measuring Erosive Gastritis, Hizikia Fusiformis

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females 19-70 years old
  • Subjects Showing Erosive Gastritis (endoscopy)
  • Able to give informed consent

Exclusion Criteria:

  • Diagnosed of gastrointestinal disease such as ulcer, cancer within 1 months
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery
  • Taken antibiotics and stomach medicines such as steroid, bismuth compound and proton pump inhibitor within 1 months
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Hizikia Fusiformis extract

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in Erosions
    Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.
    Changes in Score of Erosions
    Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week). Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).

    Secondary Outcome Measures

    Changes in Subjects' Symptoms Total Score
    Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week). The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).
    Changes in Gastrin
    Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
    Changes in PepsinogenⅠ
    PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
    Changes in PepsinogenⅡ
    PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
    Changes in Pepsinogen Ⅰ/Ⅱ Ratio
    Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
    Changes in Hs-CRP(High Sensitivity C-reactive Protein)
    Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).

    Full Information

    First Posted
    September 7, 2012
    Last Updated
    August 20, 2019
    Sponsor
    Chonbuk National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01689701
    Brief Title
    Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chonbuk National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators performed a double-blind parallel study in a group of Subjects Showing Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks. Endoscopic observations were performed before and 4 weeks after the treatment, and the cure and improvement rates were investigated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erosive Gastritis
    Keywords
    Erosive Gastritis, Hizikia Fusiformis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hizikia Fusiformis extract
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Hizikia Fusiformis extract
    Intervention Description
    Hizikia Fusiformis extract(1.3g/d)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo(1.3g/d)
    Primary Outcome Measure Information:
    Title
    Changes in Erosions
    Description
    Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.
    Time Frame
    4 weeks
    Title
    Changes in Score of Erosions
    Description
    Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week). Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in Subjects' Symptoms Total Score
    Description
    Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week). The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).
    Time Frame
    4 weeks
    Title
    Changes in Gastrin
    Description
    Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
    Time Frame
    4 weeks
    Title
    Changes in PepsinogenⅠ
    Description
    PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
    Time Frame
    4 weeks
    Title
    Changes in PepsinogenⅡ
    Description
    PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
    Time Frame
    4 weeks
    Title
    Changes in Pepsinogen Ⅰ/Ⅱ Ratio
    Description
    Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
    Time Frame
    4 weeks
    Title
    Changes in Hs-CRP(High Sensitivity C-reactive Protein)
    Description
    Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Males and females 19-70 years old Subjects Showing Erosive Gastritis (endoscopy) Able to give informed consent Exclusion Criteria: Diagnosed of gastrointestinal disease such as ulcer, cancer within 1 months Allergic or hypersensitive to any of the ingredients in the test products History of disease that could interfere with the test products or impede their absorption, such as gastrointestinal disease or gastrointestinal surgery Taken antibiotics and stomach medicines such as steroid, bismuth compound and proton pump inhibitor within 1 months Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sang-Wook Kim, MD
    Organizational Affiliation
    Chonbuk National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis

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