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Completed

NCT Number: NCT01689701

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

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.

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Key information

Conditions

Erosive Gastritis

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Hizikia Fusiformis extract

Dietary Supplement

Hizikia Fusiformis extract(1.3g/d)

Placebo

Dietary Supplement

Placebo(1.3g/d)

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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).

  2. Changes in Gastrin

    Time frame: 4 weeks

    Gastrin was measured in study visit 1(0 week) and visit 3(4 week).

  3. Changes in PepsinogenⅠ

    Time frame: 4 weeks

    PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).

  4. Changes in PepsinogenⅡ

    Time frame: 4 weeks

    PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Sep 20, 2019

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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