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

Study Overview
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Brief Summary
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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.

Conditions
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Erosive Gastritis

Intervention / Treatment
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* Dietary Supplement: Hizikia Fusiformis extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hizikia Fusiformis extract<br> | Dietary Supplement: Hizikia Fusiformis extract<br>* Hizikia Fusiformis extract(1.3g/d)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo(1.3g/d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 
| 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). | 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erosive Gastritis, Hizikia Fusiformis