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

August 20, 2019 updated by: Soo-Wan Chae, Chonbuk National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo(1.3g/d)
Experimental: Hizikia Fusiformis extract
Dietary supplement: Hizikia Fusiformis extract
Hizikia Fusiformis extract(1.3g/d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Erosions
Time Frame: 4 weeks
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.
4 weeks
Changes in Score of Erosions
Time Frame: 4 weeks

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).
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Subjects' Symptoms Total Score
Time Frame: 4 weeks

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).
4 weeks
Changes in Gastrin
Time Frame: 4 weeks
Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
4 weeks
Changes in PepsinogenⅠ
Time Frame: 4 weeks
PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
4 weeks
Changes in PepsinogenⅡ
Time Frame: 4 weeks
PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
4 weeks
Changes in Pepsinogen Ⅰ/Ⅱ Ratio
Time Frame: 4 weeks
Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
4 weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Time Frame: 4 weeks
Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonbuk National University Hospital

Investigators

  • Principal Investigator: Sang-Wook Kim, MD, Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU-EG-ECKL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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