Functional Dyspepsia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGreen 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
DIETARY_SUPPLEMENTPlacebo group
Placebo 320 mg/day during 8 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| concentration of interferon-γ (pg/mL) | 8 weeks | interferon-γ (pg/mL) 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 |
| concentration of gastrin (pg/mL) | 8 weeks | gastrin (pg/mL) measured at baseline and after 8 weeks |
| concentration of malondialdehyde (mic·mol/L) | 8 weeks | malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks |
| 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 |
| 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. |
| 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. |
| 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 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 |
Countries
South Korea
Outcome results
None listed