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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hizikia Fusiformis extract | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hizikia Fusiformis extract | Dietary Supplement | Hizikia Fusiformis extract(1.3g/d) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Wook Kim, MD | Chonbuk National University Hospital | Principal Investigator |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hizikia Fusiformis Extract | Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated |
| FG001 | Placebo | Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hizikia Fusiformis Extract | Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | erosions | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hizikia Fusiformis Extract | Hizikia Fusiformis extract(1.3g/d) for 12weeks Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sang-Wook Kim, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | clickm@jbnu.ac.kr |
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| Placebo | Dietary Supplement | Placebo(1.3g/d) |
|
| Changes in Gastrin | Gastrin was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks |
| Changes in PepsinogenⅠ | PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks |
| Changes in PepsinogenⅡ | PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks |
| Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week). | 4 weeks |
| 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 |
Placebo(1.3g/day) for 4weeks
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Posted | Mean | Standard Deviation | Scores on a scale | 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). | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Secondary | Changes in Gastrin | Gastrin was measured in study visit 1(0 week) and visit 3(4 week). | Posted | Mean | Standard Deviation | pg/ml | 4 weeks |
|
|
|
| Secondary | Changes in PepsinogenⅠ | PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week). | Posted | Mean | Standard Deviation | ng/mL | 4 weeks |
|
|
|
| Secondary | Changes in PepsinogenⅡ | PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week). | Posted | Mean | Standard Deviation | ng/ml | 4 weeks |
|
|
|
| Secondary | Changes in Pepsinogen Ⅰ/Ⅱ Ratio | Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week). | Posted | Mean | Standard Deviation | ratio | 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). | Posted | Mean | Standard Deviation | mg/L | 4 weeks |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Placebo | Placebo(1.3g/day) for 4weeks Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract. | 0 | 27 | 0 | 27 |
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