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

NCT ID: NCT01689701

Last Updated: 2019-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-04-30

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.

Detailed Description

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Conditions

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Erosive Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hizikia Fusiformis extract

Group Type EXPERIMENTAL

Hizikia Fusiformis extract

Intervention Type DIETARY_SUPPLEMENT

Hizikia Fusiformis extract(1.3g/d)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo(1.3g/d)

Interventions

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Hizikia Fusiformis extract

Hizikia Fusiformis extract(1.3g/d)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo(1.3g/d)

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Wook Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Other Identifiers

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PKU-EG-ECKL

Identifier Type: -

Identifier Source: org_study_id

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