Status:
COMPLETED
Effects of Green Tea Extracts on Gastric Mucosal Protection
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief 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 (epigallocatechi...
Detailed Description
A previous study has indicated that combined extract of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) may improve gastric mucosal status in rat with alcohol-induced gastr...
Eligibility Criteria
Inclusion
- 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
- 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 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
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04742985
Start Date
February 15 2021
End Date
June 30 2021
Last Update
August 2 2021
Active Locations (1)
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1
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea, 50612