Effects of Green Tea Extracts on Gastric Mucosal Protection (NCT04742985) | Clinical Trial Compass
CompletedNot Applicable
Effects of Green Tea Extracts on Gastric Mucosal Protection
South Korea24 participantsStarted 2021-02-15
Plain-language summary
The investigators conduct a randomized, double-blind, placebo-controlled pilot study to investigate the effects of a combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks.
Who can participate
Age range19 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The Rome IV criteria define dyspepsia as any combination of 4 symptoms: postprandial fullness, early satiety, epigastric pain, and epigastric burning that are severe enough to interfere with the usual activities and occur at least 3 days per week over the last 3 months
Exclusion Criteria:
* Patients complaining of severe gastrointestinal symptoms requiring immediate medication
* 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 …