Erosive Gastritis
Conditions
Keywords
Erosive Gastritis, Hizikia Fusiformis
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.
Interventions
DIETARY_SUPPLEMENTHizikia Fusiformis extract
Hizikia Fusiformis extract(1.3g/d)
DIETARY_SUPPLEMENTPlacebo
Placebo(1.3g/d)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in PepsinogenⅠ | 4 weeks | PepsinogenⅠ 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). |
| 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 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 Gastrin | 4 weeks | Gastrin was measured in study visit 1(0 week) and visit 3(4 week). |
Participant flow
Recruitment details
The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2011. Only those subjects who were Subjects Showing Erosive Gastritis and were not diagnosed with any disease were included in this study.
Pre-assignment details
Among the 79 subjets screened, 25 subjects had endoscopy and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Hizikia Fusiformis Extract Hizikia Fusiformis extract(1.3g/d) for 12weeks
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated | 27 |
| Placebo Placebo(1.3g/day) for 4weeks
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract. | 27 |
| Total | 54 |
Baseline characteristics
| Characteristic | Placebo | Hizikia Fusiformis Extract | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 27 Participants | 54 Participants |
| Age, Continuous | 38.7 years STANDARD_DEVIATION 10 | 39.1 years STANDARD_DEVIATION 11.9 | 38.9 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Korea, Republic of | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 22 Participants | 18 Participants | 40 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Erosions | Pre | 4.36 erosions | Standard Deviation 2.48 |
| Hizikia Fusiformis Extract | Changes in Erosions | Post | 2.32 erosions | Standard Deviation 2.1 |
| Placebo | Changes in Erosions | Pre | 3.38 erosions | Standard Deviation 2.89 |
| Placebo | Changes in Erosions | Post | 2.43 erosions | Standard Deviation 3.28 |
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).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Score of Erosions | Pre | 3.00 Scores on a scale | Standard Deviation 0.76 |
| Hizikia Fusiformis Extract | Changes in Score of Erosions | Post | 2.23 Scores on a scale | Standard Deviation 0.92 |
| Placebo | Changes in Score of Erosions | Pre | 2.71 Scores on a scale | Standard Deviation 0.78 |
| Placebo | Changes in Score of Erosions | Post | 2.05 Scores on a scale | Standard Deviation 1.12 |
Secondary
Changes in Gastrin
Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Gastrin | Pre | 37.36 pg/ml | Standard Deviation 16.43 |
| Hizikia Fusiformis Extract | Changes in Gastrin | Post | 32.05 pg/ml | Standard Deviation 15.27 |
| Placebo | Changes in Gastrin | Pre | 36.44 pg/ml | Standard Deviation 16.88 |
| Placebo | Changes in Gastrin | Post | 27.61 pg/ml | Standard Deviation 10.86 |
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).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Hs-CRP(High Sensitivity C-reactive Protein) | Post | 0.23 mg/L | Standard Deviation 0.4 |
| Hizikia Fusiformis Extract | Changes in Hs-CRP(High Sensitivity C-reactive Protein) | Pre | 0.63 mg/L | Standard Deviation 1.24 |
| Placebo | Changes in Hs-CRP(High Sensitivity C-reactive Protein) | Pre | 0.16 mg/L | Standard Deviation 0.19 |
| Placebo | Changes in Hs-CRP(High Sensitivity C-reactive Protein) | Post | 0.75 mg/L | Standard Deviation 2.01 |
Secondary
Changes in PepsinogenⅠ
PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in PepsinogenⅠ | Pre | 50.15 ng/mL | Standard Deviation 14.78 |
| Hizikia Fusiformis Extract | Changes in PepsinogenⅠ | Post | 55.28 ng/mL | Standard Deviation 19.08 |
| Placebo | Changes in PepsinogenⅠ | Pre | 54.72 ng/mL | Standard Deviation 16.24 |
| Placebo | Changes in PepsinogenⅠ | Post | 57.96 ng/mL | Standard Deviation 19.42 |
Secondary
Changes in PepsinogenⅡ
PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in PepsinogenⅡ | Pre | 13.40 ng/ml | Standard Deviation 8.38 |
| Hizikia Fusiformis Extract | Changes in PepsinogenⅡ | Post | 15.39 ng/ml | Standard Deviation 10.16 |
| Placebo | Changes in PepsinogenⅡ | Pre | 12.65 ng/ml | Standard Deviation 7.46 |
| Placebo | Changes in PepsinogenⅡ | Post | 13.66 ng/ml | Standard Deviation 8.09 |
Secondary
Changes in Pepsinogen Ⅰ/Ⅱ Ratio
Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Pre | 4.66 ratio | Standard Deviation 1.86 |
| Hizikia Fusiformis Extract | Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Post | 4.56 ratio | Standard Deviation 1.84 |
| Placebo | Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Pre | 5.17 ratio | Standard Deviation 1.83 |
| Placebo | Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Post | 5.07 ratio | Standard Deviation 1.73 |
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).
Time frame: 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hizikia Fusiformis Extract | Changes in Subjects' Symptoms Total Score | Pre | 2.77 Units on a scale | Standard Deviation 2.56 |
| Hizikia Fusiformis Extract | Changes in Subjects' Symptoms Total Score | Post | 2.77 Units on a scale | Standard Deviation 3.18 |
| Placebo | Changes in Subjects' Symptoms Total Score | Pre | 3.90 Units on a scale | Standard Deviation 4.15 |
| Placebo | Changes in Subjects' Symptoms Total Score | Post | 2.57 Units on a scale | Standard Deviation 3.37 |