Erosive GastritisNCT01689701
Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
A study testing Hizikia Fusiformis extract in people with Erosive Gastritis, run by Chonbuk National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Erosive Gastritis
- What is being tested?
- Hizikia Fusiformis extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 19-70 years old
- Subjects Showing Erosive Gastritis (endoscopy)
- Able to give informed consent
Who cannot join
- 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.
About this study
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
- Being tested
- Hizikia Fusiformis extract, Placebo
- Keywords
- Erosive Gastritis, Hizikia Fusiformis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hizikia Fusiformis extractDietary supplement
Hizikia Fusiformis extract(1.3g/d)
PlaceboDietary supplement
Placebo(1.3g/d)
| Study group | Role | What they receive |
|---|---|---|
| Hizikia Fusiformis extract | Experimental | Not described Receives: Dietary Supplement: Hizikia Fusiformis extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 4 weeks
Secondary outcomes (6)
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).
Measured: 4 weeks
Changes in Gastrin
Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
Measured: 4 weeks
Changes in PepsinogenⅠ
PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
Measured: 4 weeks
Changes in PepsinogenⅡ
PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
Measured: 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).
Measured: 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).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erosive GastritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Sang-Wook Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689701
- Sponsor's protocol ID
- PKU-EG-ECKL
- Status last verified
- Aug 2019
- First submitted
- 7 Sep 2012
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis
- ClinicalTrials.gov ID
- NCT01689701
- Acronym / sponsor ID
- PKU-EG-ECKL
- Conditions
- Erosive Gastritis
- Keywords
- Erosive Gastritis, Hizikia Fusiformis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hizikia Fusiformis extract | Experimental | Dietary Supplement: Hizikia Fusiformis extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 19-70 years old
- Subjects Showing Erosive Gastritis (endoscopy)
- Able to give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hizikia Fusiformis extractHizikia Fusiformis extract(1.3g/d) | Dietary supplement | Hizikia Fusiformis extract |
| PlaceboPlacebo(1.3g/d) | Dietary supplement | Placebo |
Primary outcome
Changes in Erosions
Time frame: 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
Time frame: 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).
6 secondary outcomes
Changes in Subjects' Symptoms Total Score
Time frame: 4 weeks
Changes in Gastrin
Time frame: 4 weeks
Changes in PepsinogenⅠ
Time frame: 4 weeks
Changes in PepsinogenⅡ
Time frame: 4 weeks
Changes in Pepsinogen Ⅰ/Ⅱ Ratio
Time frame: 4 weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Wook Kim, MD principal investigator
Chonbuk National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hizikia Fusiformis extract in people with Erosive Gastritis, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Erosions (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.