N/A
N=54
Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
Erosive Gastritis
Bottom Line
View on ClinicalTrials.gov: NCT01689701 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Changes in Erosions — 4.36; 3.38; 2.32; 2.43 erosions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hizikia Fusiformis extract (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Erosions |
4.36; 3.38; 2.32; 2.43 | — |
| PRIMARY Changes in Score of Erosions |
3.00; 2.71; 2.23; 2.05 | — |
| SECONDARY Changes in Subjects' Symptoms Total Score |
2.77; 3.90; 2.77; 2.57 | — |
| SECONDARY Changes in Gastrin |
37.36; 36.44; 32.05; 27.61 | — |
| SECONDARY Changes in PepsinogenⅠ |
50.15; 54.72; 55.28; 57.96 | — |
| SECONDARY Changes in PepsinogenⅡ |
13.40; 12.65; 15.39; 13.66 | — |
| SECONDARY Changes in Pepsinogen Ⅰ/Ⅱ Ratio |
4.66; 5.17; 4.56; 5.07 | — |
| SECONDARY Changes in Hs-CRP(High Sensitivity C-reactive Protein) |
0.63; 0.16; 0.23; 0.75 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01689701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.