Effects of Green Tea Extracts on Gastric Mucosal Protection
- Conditions
- Functional Dyspepsia
- Registration Number
- NCT04742985
- Lead Sponsor
- Pusan National University Yangsan Hospital
- 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 (epigallocatechin-3-gallate) on gastric mucosal protection in adults with functional dyspepsia for 8 weeks.
- 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 gastritis.Therefore, 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; the safety of the compound are also evaluated. The Investigators examine C-reactive protein, IFN-γ, TNF-α, gastrin, malondialdehyde, 8-hydroxy-2' -deoxyguanosine, and questionnaires (Gastrointestinal Symptom Rating Scale, Nepean dyspepsia index-Korean version, Nepean dyspepsia index-Korean version QOL questionnaire, Gastrointestinal symptom scale) at baseline and after 8 weeks of intervention. Twenty four adults were administered either 320 mg of combined extracts of green tea seed (saponins) and green tea leaves (epigallocatechin-3-gallate) or a placebo each day for 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Gastrointestinal Symptom Rating Scale (score) 8 weeks Gastrointestinal Symptom Rating Scale - questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 75. A higher score indicates a worse outcome.
- Secondary Outcome Measures
Name Time Method concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) 8 weeks 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) measured at baseline and after 8 weeks
Gastrointestinal symptom scale (score) 8 weeks Gastrointestinal symptom scale questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 40. A higher score indicates a worse outcome.
concentration of interferon-γ (pg/mL) 8 weeks interferon-γ (pg/mL) measured at baseline and after 8 weeks
concentration of gastrin (pg/mL) 8 weeks gastrin (pg/mL) measured at baseline and after 8 weeks
Nepean dyspepsia index-Korean version (score) 8 weeks Nepean dyspepsia index-Korean version - questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 195. A higher score indicates a worse outcome.
concentration of high-sensitivity C-reactive protein (mg/L) 8 weeks high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks
concentration of tumor necrosis factor-α (pg/mL) 8 weeks interferon-γ (pg/mL) measured at baseline and after 8 weeks measured at baseline and after 8 weeks
Nepean dyspepsia index-Korean version QOL questionnaire (score) 8 weeks Nepean dyspepsia index-Korean version QOL questionnaire evaluated at baseline and after 8 weeks. It ranges from the minimum of 0 to the maximum of 125. A higher score indicates a worse outcome.
concentration of malondialdehyde (mic·mol/L) 8 weeks malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeungsangnam-do, Korea, Republic of
Pusan National University Yangsan Hospital🇰🇷Yangsan, Gyeungsangnam-do, Korea, Republic of