Functional DyspepsiaNCT04742985
Effects of Green Tea Extracts on Gastric Mucosal Protection
A study testing Green tea combined extracts group in people with Functional Dyspepsia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Green tea combined extracts group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
Official title: Effects of Combined Extracts of Green Tea Seed (Saponins) and Green Tea Leaves (Epigallocatechin-3-gallate) on Gastric Mucosal Protection: A Pilot Study
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.
Read the 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.
- Conditions
- Functional Dyspepsia
- Being tested
- Green tea combined extracts group, Placebo group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green tea combined extracts groupDietary supplement
Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
Placebo groupDietary supplement
Placebo 320 mg/day during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Green tea combined extracts group A | Experimental | This group takes Green tea combined extracts (62.5 mg) for 8 weeks. Receives: Dietary Supplement: Green tea combined extracts group |
| Green tea combined extracts group B | Experimental | This group takes Green tea combined extracts (125 mg) for 8 weeks. Receives: Dietary Supplement: Green tea combined extracts group |
| Placebo group | Placebo comparator | This group takes placebo for 8 weeks. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale (score)
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.
Measured: 8 weeks
Secondary outcomes (9)
concentration of high-sensitivity C-reactive protein (mg/L)
high-sensitivity C-reactive protein (mg/L) measured at baseline and after 8 weeks
Measured: 8 weeks
concentration of interferon-γ (pg/mL)
interferon-γ (pg/mL) measured at baseline and after 8 weeks
Measured: 8 weeks
concentration of tumor necrosis factor-α (pg/mL)
interferon-γ (pg/mL) measured at baseline and after 8 weeks measured at baseline and after 8 weeks
Measured: 8 weeks
concentration of gastrin (pg/mL)
gastrin (pg/mL) measured at baseline and after 8 weeks
Measured: 8 weeks
concentration of malondialdehyde (mic·mol/L)
malondialdehyde (mic·mol/L) measured at baseline and after 8 weeks
Measured: 8 weeks
concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein)
8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein) measured at baseline and after 8 weeks
Measured: 8 weeks
Nepean dyspepsia index-Korean version (score)
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.
Measured: 8 weeks
Nepean dyspepsia index-Korean version QOL questionnaire (score)
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.
Measured: 8 weeks
Gastrointestinal symptom scale (score)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start15 Feb 2021
- Primary completion29 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742985
- Sponsor's protocol ID
- 02-2020-048
- Status last verified
- Jul 2021
- First submitted
- 3 Feb 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Extracts of Green Tea Seed (Saponins) and Green Tea Leaves (Epigallocatechin-3-gallate) on Gastric Mucosal Protection: A Pilot Study
- ClinicalTrials.gov ID
- NCT04742985
- Acronym / sponsor ID
- 02-2020-048
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Green tea combined extracts group A | Experimental | Dietary Supplement: Green tea combined extracts groupThis group takes Green tea combined extracts (62.5 mg) for 8 weeks. |
| Green tea combined extracts group B | Experimental | Dietary Supplement: Green tea combined extracts groupThis group takes Green tea combined extracts (125 mg) for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThis group takes placebo for 8 weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green tea combined extracts groupGreen tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks | Dietary supplement | Green tea combined extracts group A, Green tea combined extracts group B |
| Placebo groupPlacebo 320 mg/day during 8 weeks | Dietary supplement | Placebo group |
Primary outcome
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.
9 secondary outcomes
concentration of high-sensitivity C-reactive protein (mg/L)
Time frame: 8 weeks
concentration of interferon-γ (pg/mL)
Time frame: 8 weeks
concentration of tumor necrosis factor-α (pg/mL)
Time frame: 8 weeks
concentration of gastrin (pg/mL)
Time frame: 8 weeks
concentration of malondialdehyde (mic·mol/L)
Time frame: 8 weeks
concentration of 8-hydroxy-2' -deoxyguanosine (ng/100 mg of protein)
Time frame: 8 weeks
Nepean dyspepsia index-Korean version (score)
Time frame: 8 weeks
Nepean dyspepsia index-Korean version QOL questionnaire (score)
Time frame: 8 weeks
Gastrointestinal symptom scale (score)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green tea combined extracts group in people with Functional Dyspepsia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale (score) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.