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

NCT01689701 | Completed Results DMC

• 1 other identifier: PKU-EG-ECKL
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erosive Gastritis

Keywords

Erosive Gastritis; Hizikia Fusiformis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Changes in Subjects' Symptoms Total Score

  4 weeks

• Changes in Gastrin

  4 weeks

• Changes in PepsinogenⅠ

  4 weeks

• Changes in PepsinogenⅡ

  4 weeks

• Changes in Pepsinogen Ⅰ/Ⅱ Ratio

  4 weeks

Study Arms (2)

Hizikia Fusiformis extract

EXPERIMENTAL

Dietary Supplement: Hizikia Fusiformis extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Hizikia Fusiformis extract DIETARY_SUPPLEMENT

Hizikia Fusiformis extract(1.3g/d)

Hizikia Fusiformis extract

Placebo DIETARY_SUPPLEMENT

Placebo(1.3g/d)

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 19-70 years old
• Subjects Showing Erosive Gastritis (endoscopy)
• Able to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Results Point of Contact

• Title: Dr. Sang-Wook Kim, MD
• Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

clickm@jbnu.ac.kr

82-63-276-8284

Study Officials

• Sang-Wook Kim, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 21, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: April 1, 2012
• Last Updated: September 20, 2019
• Results First Posted: September 20, 2019

Record last verified: 2019-08