Effects of Green Tea Extracts on Gastric Mucosal Protection
NCT ID: NCT04742985
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2021-02-15
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Green tea combined extracts group A
This group takes Green tea combined extracts (62.5 mg) for 8 weeks.
Green tea combined extracts group
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
Green tea combined extracts group B
This group takes Green tea combined extracts (125 mg) for 8 weeks.
Green tea combined extracts group
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
Placebo group
This group takes placebo for 8 weeks.
Placebo group
Placebo 320 mg/day during 8 weeks
Interventions
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Green tea combined extracts group
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
Placebo group
Placebo 320 mg/day during 8 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Those with a history of gastric acid hypersecretion such as Zollinger-Ellison Syndrome
* Those who received Helicobacter pylori eradication therapy within 4 weeks
* Those who have taken nonsteroidal anti-inflammatory drugs, steroid drugs or antibiotics, aspirin or antithrombotic drugs, or gastric acid suppressants within 4 weeks
* Those who have a history of upper gastrointestinal tract surgery, stenosis, bleeding, esophageal dilatation, gastric mucosal resection, etc. within the past 1 year
* Patients with gastric ulcer (active or healing), duodenal ulcer (active or healing), reflux esophagitis (LA B or higher), or malignant tumors from gastroscopy performed within the last 6 months
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* History of fracture during the previous year
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
* History of any central bone fracture within 1 year
* History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
* Alcohol abuser
* Allergic reaction to Ishige Okamurae
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons
19 Years
75 Years
ALL
Yes
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Sang Yeoup Lee
Professor
Principal Investigators
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Sang Yeoup Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
Countries
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Other Identifiers
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02-2020-048
Identifier Type: -
Identifier Source: org_study_id
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