Functional DysphoniaNCT06628804
Artemisia and Green Tea Extracts for Gastric Mucosal Health
A study testing Artemisia and green tea extracts in people with Functional Dysphonia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
This clinical trial aims to determine whether Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety. The main questions are: Does Artemisia and green tea extracts promote gastric mucosal health in participants? What side effects occur when… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dysphonia
- What is being tested?
- Artemisia and green tea extracts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2024to 31 Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rome IV-based functional dyspepsia-
Who cannot join
- Patients with gastrointestinal symptoms requiring immediate drug treatment.
- Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.
- Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.
- Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.
- Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year.
- Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy.
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- Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg).
- Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL).
- Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution.
- Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution.
- Alcohol abusers.
- Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders).
- Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period.
- Individuals with allergies to any components of the study foods.
- Individuals who participated in or plan to participate in another drug clinical trial within the last month.
- Individuals deemed unsuitable for the study by the investigator for other reasons.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, 50612
About this study
Official title: Effects of Artemisia and Green Tea Extracts on Promoting Gastric Mucosal Health in Adults With Functional Dyspepsia: A Randomized, Double-blind, Placebo-controlled Clinical Trial
This clinical trial aims to determine whether Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety.
The main questions are:
- Does Artemisia and green tea extracts promote gastric mucosal health in participants?
- What side effects occur when participants take Artemisia and green tea extracts?
Read the detailed description
Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.
Participants will:
- Take Artemisia and green tea extracts or a placebo daily for 8 weeks.
- Visit the clinic every 4 weeks for checkups and tests.
- Conditions
- Functional Dysphonia
- Being tested
- Artemisia and green tea extracts, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisia and green tea extractsDietary supplement
Artemisia and green tea extracts 700 mg/day for 8 weeks
PlaceboDietary supplement
Placebo 700 mg/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Artemisia and green tea extracts group | Experimental | This group takes Artemisia and green tea extracts for 8 weeks. Receives: Dietary Supplement: Artemisia and green tea extracts |
| Placebo group | Placebo comparator | This group takes a placebo for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Korean version of the Gastrointestinal Symptom Rating Scale: Total score
Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 15 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 45, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (10)
The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen
Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 8 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 21, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Visual Analogue Scale for evaluating gastric mucosal improvement
Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Gastrointestinal symptom score
Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome. For each gastrointestinal symptom, the minimum value was 0, and the maximum value was 4, and higher scores mean a worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Patient's global assessment score
Measured at baseline and 8 weeks. The 5-point Likert scale for the Patient's Global Assessment Score is a self-reported tool where patients rate their disease activity. It uses an order scale, with 5 indicating "Very Good" and 1 indicating "Poor." The patient evaluates their condition based on this scale: Very Good-Good-Fair-Unchanged-Poor.
Measured: From enrollment to the end of treatment at 8 weeks
Pepsinogen I level (ng/mL)
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 8 weeks
Pepsinogen II level (ng/mL)
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 8 weeks
Pepsinogen I/Pepsinogen II ratio
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 8 weeks
Gastrin-17 level (ng/L)
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 8 weeks
Helicobacter pylori IgG titer (units)
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 8 weeks
High-sensitive C-reactive protein (mg/dL)
Measured at baseline and 8 weeks
Measured: From enrollment to the end of treatment at 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 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DysphoniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 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
- NCT06628804
- Sponsor's protocol ID
- 12-2024-006
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Artemisia and Green Tea Extracts on Promoting Gastric Mucosal Health in Adults With Functional Dyspepsia: A Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06628804
- Acronym / sponsor ID
- 12-2024-006
- Conditions
- Functional Dysphonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Oct 2024 (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.
This clinical trial aims to determine whether Artemisia and green tea extracts promote gastric mucosal health in adults with functional dyspepsia and to assess its safety.
The main questions are:
- Does Artemisia and green tea extracts promote gastric mucosal health in participants?
- What side effects occur when participants take Artemisia and green tea extracts?
Detailed description
Researchers will compare Artemisia and green tea extracts to placebo to evaluate their effectiveness in promoting gastric mucosal health.
Participants will:
- Take Artemisia and green tea extracts or a placebo daily for 8 weeks.
- Visit the clinic every 4 weeks for checkups and tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artemisia and green tea extracts group | Experimental | Dietary Supplement: Artemisia and green tea extractsThis group takes Artemisia and green tea extracts for 8 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group takes a placebo for 8 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rome IV-based functional dyspepsia-
Key exclusion criteria (16 listed)
- Patients with gastrointestinal symptoms requiring immediate drug treatment.
- Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.
- Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.
- Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.
- Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last 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 |
|---|---|---|
| Artemisia and green tea extractsArtemisia and green tea extracts 700 mg/day for 8 weeks | Dietary supplement | Artemisia and green tea extracts group |
| PlaceboPlacebo 700 mg/day for 8 weeks | Dietary supplement | Placebo group |
Primary outcome
The Korean version of the Gastrointestinal Symptom Rating Scale: Total score
Time frame: From enrollment to the end of treatment at 8 weeks
Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 15 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 45, and higher scores mean a worse outcome.
10 secondary outcomes
The Korean version of the Gastrointestinal Symptom Rating Scale: Subtotal scores of upper abdomen
Time frame: From enrollment to the end of treatment at 8 weeks
Visual Analogue Scale for evaluating gastric mucosal improvement
Time frame: From enrollment to the end of treatment at 8 weeks
Gastrointestinal symptom score
Time frame: From enrollment to the end of treatment at 8 weeks
Patient's global assessment score
Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen I level (ng/mL)
Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen II level (ng/mL)
Time frame: From enrollment to the end of treatment at 8 weeks
Pepsinogen I/Pepsinogen II ratio
Time frame: From enrollment to the end of treatment at 8 weeks
Gastrin-17 level (ng/L)
Time frame: From enrollment to the end of treatment at 8 weeks
Helicobacter pylori IgG titer (units)
Time frame: From enrollment to the end of treatment at 8 weeks
High-sensitive C-reactive protein (mg/dL)
Time frame: From enrollment to the end of treatment at 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 13 Jan 2026.
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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 Artemisia and green tea extracts in people with Functional Dysphonia, 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 16 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 13 Jan 2026. 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?
The Korean version of the Gastrointestinal Symptom Rating Scale: Total score (time frame: From enrollment to the end of treatment at 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 13 Jan 2026.