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

Not Applicable

Completed

• Conditions: Erosive Gastritis
• Interventions: Dietary Supplement: Hizikia Fusiformis extract; Dietary Supplement: Placebo

• Registration Number: NCT01689701
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2012-04
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-21
• Results First Submitted: 2012-09-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Results First Posted: 2019-09-20
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hizikia Fusiformis extract	Hizikia Fusiformis extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in Erosions	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.
Changes in Score of Erosions	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 Outcome Measures

Name	Time	Method
Changes in PepsinogenⅠ	4 weeks	PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
Changes in Gastrin	4 weeks	Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
Changes in Pepsinogen Ⅰ/Ⅱ Ratio	4 weeks	Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
Changes in Subjects' Symptoms Total Score	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).
Changes in Hs-CRP(High Sensitivity C-reactive Protein)	4 weeks	Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).
Changes in PepsinogenⅡ	4 weeks	PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).