Effects of Combined Extracts of Green Tea Seed (Saponins) and Green Tea Leaves (Epigallocatechin-3-gallate) on Gastric Mucosal Protection: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Gastrointestinal Symptom Rating Scale (score)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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
Outcomes
Primary Outcomes
Gastrointestinal Symptom Rating Scale (score)
Time Frame: 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 Outcomes
- concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein)(8 weeks)
- Gastrointestinal symptom scale (score)(8 weeks)
- concentration of interferon-γ (pg/mL)(8 weeks)
- concentration of gastrin (pg/mL)(8 weeks)
- Nepean dyspepsia index-Korean version (score)(8 weeks)
- concentration of high-sensitivity C-reactive protein (mg/L)(8 weeks)
- concentration of tumor necrosis factor-α (pg/mL)(8 weeks)
- Nepean dyspepsia index-Korean version QOL questionnaire (score)(8 weeks)
- concentration of malondialdehyde (mic·mol/L)(8 weeks)
Investigators
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital