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

Erosive Gastritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689701
• Other study ID #: PKU-EG-ECKL
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Erosive Gastritis
• Gastritis
• Gastrointestinal Hemorrhage

Intervention

Dietary Supplement:
• Hizikia Fusiformis extract
Hizikia Fusiformis extract(1.3g/d)
• Placebo
Placebo(1.3g/d)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Changes in Gastrin	Gastrin was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks
Secondary	Changes in Pepsinogen?	Pepsinogen? was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks
Secondary	Changes in Pepsinogen?	Pepsinogen? was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks
Secondary	Changes in Pepsinogen ?/? Ratio	Pepsinogen ?/? ratio was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks
Secondary	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